Currently browsing posts about: Probiotics

This one started out with a notice in NutraIngredients Europe, a newsletter I subscribe to:

Probiotic BG01-4 relieves constipation and discomfort in GI disorders: Probiotic BG01-4 improves specific symptoms of constipation and related GI dysfunction in people with self-reported functional gastrointestinal disorders (FGID), which affects a significant percentage of the global population, a new study concludes…. Read more

That title triggered my usual question, “Who paid for this?”

I went right to the study:

All articles published in Nutrients (ISSN 2072-6643) are published in full open access. An article processing charge (APC) of CHF 2900 (Swiss Francs) applies to papers accepted after peer review. This article processing charge is to cover the costs of peer review, copyediting, typesetting, long-term archiving, and journal management. In addition to Swiss francs (CHF), we also accept payment in euros (EUR), US dollars (USD), British pound sterling (GBP), Japanese yen (JPY) or Canadian dollars (CAD).

I read about this one in NutraIngredients.com.

While previous animal studies have suggested a significant impact of the gut microbiota on the development and maturation of brain networks that underlie emotional behaviour, fewer studies have been conducted on humans. Intake of a galacto-oligosaccharides (GOS) prebiotic over 3 weeks has been shown to lower the secretion of the stress hormone cortisol and emotional processing in healthy adults, suggesting that GOS intake may be useful in modifying anxiety-related psychological mechanisms. However, reviews and meta-analyses on the efficacy of prebiotics for reducing anxiety symptomology are mixed, calling for further well controlled trials in human participants.

I am always curious to know who pays for this kind of research, so I looked up the study.

Anxiolytic effects of a galacto-oligosaccharides prebiotic in healthy females (18-25 years) with corresponding changes in gut bacterial composition.  Nicola Johnstone , Chiara Milesi , Olivia Burn, Bartholomeus van den Bogert, Arjen Nauta , Kathryn Hart , Paul Sowden, Philip W J Burnet, Kathrin Cohen Kadosh.   Sci Rep 2021 Apr 15;11(1):8302.

The study: “We examined multiple indices of mood and well-being in 64 healthy females in a 4-week double blind, placebo controlled galacto-oligosaccharides (GOS) prebiotic supplement intervention and obtained stool samples at baseline and follow-up for gut microbiota sequencing and analyses. We report effects of the GOS intervention on self-reported high trait anxiety, attentional bias, and bacterial abundance, suggesting that dietary supplementation with a GOS prebiotic may improve indices of pre-clinical anxiety.”

Conflict of interest statement: AN is an employee of FrieslandCampina, Amersfoort, The Netherlands. BvdB reports co-ownership of MyMicroZoo, Leiden, The Netherlands with no financial benefit from contributions to this manuscript. NJ, CM, OB, KH, PS, PWJB and KCK declared no financial or potential conflicts of interest.

Comment:  Probiotics are microorganisms that maintain a healthy microbiome.   They are typically found in fermented foods like yogurt.  Prebiotics are substances in food—or, in this case, supplements—that feed probiotic microbes.  This prebiotic supplement is GOS, a complicated chain of sugar molecules that is found in milk.

Why would an employee of FrieslandCampina want to do this study?  “Milk is the foundation of everything we do at FrieslandCampina.”

Why would a co-owner of MyMicroZoo be interested?  “The MyMicroZoo analysis shows the composition of your microbiota, and gives insight into how to improve your vitality.”

I’m all for eating yogurt (but watch out for the added sugars).  But GOS supplements?  Pardon my industry-induced skepticism.

My colleague, former doctoral student, and frequent correspondent, Dr. Lisa Young, sent me this choice item:

Now why would PepsiCo be interested in putting money into a conference on fermented foods?

Lisa has the answer to that one too: the company just bought a company that makes fermented beverages.

PepsiCo, Inc. (NYSE: PEP) announced today that it has entered into a definitive agreement to acquire KeVita, a leading North American creator of fermented probiotic and kombucha beverages. The transaction will expand PepsiCo’s health and wellness offerings in the premium chilled beverage space.

I’ll bet speakers at that conference talked a lot about the purported health benefits of drinks like these.  And I’ll also be willing to bet that they did not talk about studies that show no benefit.

Just a wild guess.

NutraIngredients.com, one of those industry newsletters I follow closely, publishes numerous articles on probiotics, gut health, and the microbiome.  I have a few examples here, but let’s start with this one:

• Postbiotics show promise, even if method of action is unclear:  The use of postbiotics could be an attractive alternative to prebiotics in immunocompromised children and adults, according to a recent review. But the lack of a definition of the term is still a complicating factor in determining effectiveness.

Postbiotics?  For this, a glossary may help:

• Probiotics:  Beneficial microbes in the intestinal tract
• Prebiotics:  Food substances that promote the growth of probiotics
• Synbiotics:  Probiotics and Prebiotics together
• Postbiotics:  Bioactive substances produced by probiotics (e.g., microbial cells, cell constituents, metabolites).
• Parabiotics:  Heat-killed microorganisms

More articles on these topics:

• Bill Gates: ‘Probiotics key to solving malnutrition’:  Probiotics could be key in addressing malnutrition, according to Bill Gates, who calls the nutritional imbalances affecting around 200 million children under five ‘the greatest health inequity in the world.’ Read more
• Gut health collaboration: Carbiotix and Food Marble to team up over microbiome health research:  Swedish gut health analysis player Carbiotix is set to collaborate with Dublin-based digestive health tracking firm Food Marble to conduct an eight week study to understand the correlation between digestive health data and gut microbiome data. Read more
• Microbiome profiling: Study uncovers ‘comprehensive’ list of organisms that make a healthy gut:  There are 157 organisms that form the ‘baseline biome’ of a healthy human gut, according to new research published in PLoS One. Read more
• Study: Gut health most influenced by teams of bacteria:  Gut microbial species work in teams to perform different functions, suggesting that cultivating certain groups of bacteria is more important than single species, according to an international team of researchers. Read more
• Strategic thinking: Brilliant science is only half of the battle for microbiome success:  When it comes to commercialising microbiome-related products, having really amazing science is only 50% of the journey towards market success, says industry expert Julian Mellentin… Read
• Nespresso-style gut health: Bioengineer creates personalised probiotic yoghurt machine:  A Swedish startup is on a mission to make yoghurt truly good for the gut with a kitchen counter machine that makes personalised probiotic and prebiotic filled yogurts, the founder tells NutraIngredients ahead of her debut as a Probiota Pioneer next month… Read
• Pioneering scientists create designer prebiotics to disrupt the microbiome health space:  A team of top scientists leading the way in designer prebiotics has been selected as one of the most pioneering startups in the microbiome health industry… Read
• Prebiotics stamp authority in deciding gut health and overall wellbeing:  Studies pointing to prebiotics as modulators of the microbiome-gut-brain axis could see the non-digestible food ingredient become a basis for preventing the rise in obesity and diabetic cases… Read
• Hitting a nerve: The link between vagal stimulation, the gut and depression:  Recognising biologically similar pathways in those with depression could result in a precision led approach that points people towards more effective methods to address the neurological condition… Read

And Natural Products Insider has a report on prebiotic supplements available for downloading.

FoodNavigator-USA.com, an industry newsletter, has a collection of articles about Kombucha, a drink that Wikipedia defines as:

A fermented, slightly alcoholic, lightly effervescent, sweetened black or green tea drink commonly intended as a functional beverage for its supposed health benefits. Sometimes the beverage is called kombucha tea to distinguish it from the culture of bacteria and yeast.  Juice, spices, or other flavorings are often added to enhance the taste of the beverage. The exact origins of kombucha are not known…Kombucha is produced by fermenting sugared tea using a symbiotic culture of bacteria and yeast (SCOBY) commonly called a “mother” or “mushroom”…The living bacteria are said to be probiotic, one of the reasons for the drink’s popularity.

Slightly alcoholic?  No wonder it is so popular.

It’s obviously a major seller.  Here is the dedicated Kombucha display at the Wegmans upstate in Ithaca, New York.

The makers of kombucha want to sell more of it.  Here’s what they think the market issues are these days:

• Aqua ViTea: The kombucha industry has not dealt with its alcohol problem: <Raising the threshold above which kombucha would be classified as an alcoholic beverage from 0.5% to 1.25% abv, is not the way to deal with the industry’s alcohol problem, says Vermont-based kombucha brand Aqua ViTea, which utilizes spinning cone technology to remove most of the alcohol from its products before bottling… Read
• GT Dave backs kombucha standard of identity: ‘I hope this will encourage people to take the high road’: Defining what kombucha is – and just as importantly, what it isn’t – is mission critical if industry pioneers are to preserve the integrity of the category as more brands enter the segment, argues GT Dave, founder of market leader GT’s Living Foods… Read  
• WATCH: Bare Bucha and Stout Tanks unveil radical new approach to controlling alcohol in kombucha:  A novel approach to brewing kombucha in stackable rectangular trays could help dramatically speed up the fermentation process and keep alcohol levels consistently below 0.5% abv, solving a major technical challenge for the industry, according to kombucha brand Bare Bucha and craft brewery equipment supplier Stout Tanks… Watch now
• Kombucha and fermented beverage sales are up 21%, but velocities are down, says SPINS:  US retail sales of refrigerated kombucha and other fermented beverages (including hard kombucha) were up 21% to $728.8m in measured channels* in the year to February 24, 2019 driven by strong distribution gains. However, velocities were down fairly sharply, delegates at the 2019 KombuchaKon conference were told… Read
• What’s an ‘authentic’ kombucha? Let the market decide, say Rowdy Mermaid and Camellia Grove:  Trade association Kombucha Brewers International (KBI) wants lawmakers to raise the threshold above which kombucha would be classified as an alcoholic beverage from 0.5% to 1.25% abv, and is gearing up to publish a standard of identity for ‘authentic’ kombucha. But not everyone is on board… Read
• What is an ‘authentic’ kombucha? KBI gears up to publish definition:  As a wave of lawsuits has brought the debate over what kombucha is and how it is made into sharper focus, trade association Kombucha Brewers International (KBI) is putting the finishing touches on a standard it claims will help preserve the integrity of the category as it grows… Read

And here’s a later addition:

• The mojo behind MOJO: Coca-Cola’s recently acquired kombucha brand shares secrets of success: Australian firm MOJO Kombucha’s pledge to authenticity and no artificial sweeteners are what have helped it grow from a small family business to becoming a major name in the country, and recently being acquired by beverage giant Coca-Cola, according to a top company official…Read

The industry newsletter, NutraIngredients.com, regularly posts Special Editions on Probiotics, meaning collections of its articles on the topic.  These promote the benefits—to digestion and many other physiological and mental aspects—of eating healthy bacteria.   But do probiotics really work?  And could they actually be harmful?  See comments below these selected articles.

• • Baby faeces’ ‘good bacteria’ a solid basis for disease-tackling probiotic supplement: ‘Good bacteria’ found in infant faeces could form the basis of a probiotic supplement that could help lower disease risk as researchers point to babies’ good health and absence of age-related diseases as good starting points… Read 
  • Survival of the fittest: Gut colonisation study could lead to gene-targeting probiotics: New probiotic products targeting individual genes for gut microbial diversity could be on the horizon after researchers outline a data-based approach that identifies the growth of beneficial microbes… Read 
  • Use of probiotics linked to brain sluggishness and stomach bloating: Study:  The use of probiotics could lead to a build-up of bacteria in the gut causing brain fogginess, US researchers conclude, as they also note its use is linked to bloating of the stomach… Read
  • No BBC, probiotics are not ‘quite useless’: A new BBC article dismisses the benefits of probiotics because a study failed to find colonization. It is a serious mistake to confuse colonization with efficacy and we need to get this message across to consumers… Read  
  • Delivery systems a ‘determining factor’ in probiotic success, suggests Lumina Intelligence: Delivery systems for probiotic supplements will determine probiotic storage, release time and viability through the body, according to recent research with these systems’ ability largely determining product success… Read  
  • Prebiotics as a concept still not well understood by many consumers, experts say: Research done by the Global Prebiotic Association shows that prebiotics as a concept is gaining traction with dedicated supplement users but has a long way to go to gain mainstream acceptance… Read
  • Focus on functional sports benefits seen as growing opportunity within microbiome research: Research in the effects of exercise on the microbiome has boosted not just a recent startup, but will fuel a growing category within the wider field of probiotics, an expert says… Read
  • Why PepsiCo, Coca-cola are betting on functional food and beverage brands: Legacy CPG companies PepsiCo and Coca-Cola have each snapped up or invested heavily in a functional food and beverage brand this year… Read
  • Highlights from the Harvard Probiotics Symposium: The recent Harvard Probiotics Symposium brought together scientific experts from across the globe to discuss: “Gut Health, Microbiota & Probiotics Throughout the Lifespan: Dietary Influences”. Here’s what we learned… Read
  • Prebiotic combination shows metabolic benefits for adults with acne: Pilot data: A combination of fructo-oligosaccharides (FOS) and galacto-oligosaccharides (GOS) prebiotics may improve glycemic and lipid metabolic measures in women with acne, suggests a small study from Italy… Read

Two recent articles in Cell raise questions about the benefits of probiotics.

• Personalized Gut Mucosal Colonization Resistance to Empiric Probiotics Is Associated with Unique Host and Microbiome Features: Probiotics transiently colonize the human gut mucosa in highly individualized patterns, thereby differentially impacting the indigenous microbiome and host gene-expression profile, a trait which is predictable by baseline host and microbiome features, but not by stool shedding.
• Post-Antibiotic Gut Mucosal Microbiome Reconstitution Is Impaired by Probiotics and Improved by Autologous FMT: Probiotics perturb rather than aid in microbiota recovery back to baseline after antibiotic treatment in humans.

In translation:

• The murine [mouse] & human gut mucosal microbiome only partially correlates with stool
• Mice feature an indigenous-microbiome driven colonization resistance to probiotics
• Humans feature a person-specific gut mucosal colonization resistance to probiotics
• Probiotic colonization is predictable by pre-treatment microbiome & host features

In further translation:

• Not everyone responds to probiotics, which means that they may be worth a try and you may get lucky.

And an even more recent article in JAMA Internal Medicine questions whether probiotics might be harmful.  It warns about:

• The safety of bacteria in probiotic supplements has not been fully established.
• They can lead to infections and allergic reactions.
• Probiotic supplements often do not meet manufacturing standards (identity, purity, strength, composition).
• Introduction of new genes for antibiotic resistance into microbiomes.

The article concludes:

Consumers and physicians should not assume that the label on probiotic supplements provides adequate information to determine if consuming the live microorganism is worth the risk.

What to think about all this?  If you like yogurt, enjoy!  But supplements are another matter.

This is one of FoodNavigator’-USA’s ongoing series of collected articles on specific topics from a food-industry perspective, in this case, digestive health.

Special Edition: Digestive health

Digestive health used to revolve around roughage, but as understanding of the relationship between our gut and our overall health has grown, consumers are now exploring everything from prebiotic fibers and probiotics to a new wave of fermented foods or simply avoiding foods that make them feel bloated or lethargic. We explore how consumers are thinking about gut health and how manufacturers can tap into demand for foods that make our microbes happy.

• How are consumers thinking about digestive health? Hartman Group weighs in: For some consumers, digestive health is about avoiding foods that make them feel bloated or lethargic, for some, it’s about ‘roughage’ and ‘regularity,’ while for others it’s about keeping their guts happy with prebiotics and probiotics, says Hartman Group… Read
• Green banana flour: A powerful new tool in the digestive health toolbox?  Milled starchy unripe bananas – which are low in sugar and high in RS2 resistant starch – can help people better control their blood glucose, but they also confer an exciting range of digestive benefits, making them a powerful new gut health ingredient, claims the firm behind NuBana green banana flour… Read
• Not all fiber is created equally, creators of resistant starch-packed Barley+ argue: Consumer demand for fiber is on the rise thanks in part to increased awareness of the ingredient’s cancer-fighting and other health benefits, but according to recent research not all fiber packs the same punch… Watch now
• Good mood food? Consumers are catching onto prebiotics, says dietitian turned food entrepreneur: While nutrition scientists are still unlocking the secrets of the gut microbiome, consumers increasingly understand that what we feed the army of microbes that line our digestive tracts may be intimately connected to our physical – and mental – health and wellbeing, says Kara Landau, the dietitian behind a new brand dedicated to gut health: Uplift: Good Mood Food… Read
• Beneo: ‘Prebiotics open a whole new door to the world of gut health that hasn’t been well explored in the US’: Brands and consumers are getting more comfortable talking about digestive health, with the conversation shifting beyond getting enough fiber for regular bowel movements, to the gut microbiome, says Beneo, which says growing interest in probiotics is helping Americans get their heads about the concept of prebiotics… Read
• Dannon continues yogurt and gut microbiome exploration with $50,000 in fellowship grants: As part of Danone North America, the Dannon Probiotics Fellowship Grant Program has awarded two graduate students with $25,000 each to help fund their independent and novel studies of yogurt, probiotics, and the human gut microbiome… Read
• Paleo On The Go sees ‘huge’ potential for convenient, auto immune protocol compliant products: With one in five Americans suffering from an auto immune disease and looking for ways to manage their conditions through diet, the market potential for foods and beverage that comply with the auto immune protocol is “huge,” and yet relatively untapped, according to one entrepreneur in the space… Read
• CHR Hansen sees growing demand for probiotics in drinkable yogurts, kids’ snacks, plant-based fermented foods: US consumers are increasingly interested in the relationship between intestinal bacteria and overall health, says CHR Hansen, but there is some confusion about which foods and beverages contain probiotics: live microorganisms that, when administered in adequate amounts, confer a health benefit on the host (according to the World Health Organization)… Read
• FDA issues guidance on added sugar, dietary fiber, serving sizes: The FDA has unveiled guidance on added sugars, serving sizes and dietary fibers to help manufacturers implement the new Nutrition Facts label, and says it’s working on a plan to incentivize manufacturers to make healthier products and “provide consumers with helpful tools to make healthy food choices, including clarity on food label claims.”.. Read
• Unique milling process qualifies Grain Millers’ oat hull fiber as ‘intrinsic and intact’ dietary fiber under FDA rules, claims company: Should oat hull fiber be classified as a dietary fiber? It depends, according to Grain Millers, which claims that its unique, mechanical milling process ensures that its oat hull fiber is the only one on the market that meets the FDA’s definition of ‘intrinsic and intact’ fibers, and queries whether oat fibers made using traditional chemical methods meet the FDA definition of ‘isolated or synthetic’ fibers either… Read
• Barrel Creek Provisions breathes new life into fermented foods: Barrel Creek Provisions has undergone a brand transformation to establish itself as a formidable player in the fermented foods category, a market that continues to grow alongside consumers’ interest in gut health and probiotics… Read

While I’m on the subject of the FTC (see yesterday’s post), let’s congratulate the agency for going after the Nestlé (no relation) corporation for marketing a product aimed at kids with misleading, deceptive, and—according to the FDA—illegal health claims.  The FTC settlement announcement says that

from fall 2008 to fall 2009, Nestlé HealthCare Nutrition, Inc. made deceptive claims in television, magazine, and print ads that BOOST Kid Essentials prevents upper respiratory tract infections in children, protects against colds and flu by strengthening the immune system, and reduces absences from daycare or school due to illness.

Nestlé must have introduced this product in 2008 because bloggers (of the sponsored kind) were promoting its benefits in September that year.  One said:

BOOST Kid Essentials is a nutritionally complete drink intended for children ages 1 to 13.  The probiotics in BOOST Kid Essentials are embedded in a straw that comes with the drink, which was prominently featured in ads for the product.  Probiotics are live, beneficial bacteria that are found naturally in many foods, and they are known for aiding digestion and fighting harmful bacteria.

This blogger’s enthusiasm for the product—“parenting solved”—quotes two studies, one done with adults using the straw and another with kids in day care whose infant formula was supplemented with one of the bacteria used in the adult study.  Both studies look preliminary to me, as they must have to the FTC.

In February 2009, in what reads like a company advertisement, another (sponsored) blogger wrote:

BOOST Kid Essentials Drink is the only nutritionally complete drink that provides kids ages 1 through 13 with immune-strengthening probiotics plus complete, balanced nutrition. Just one daily serving of the probiotic found in the BOOST Kid Essentials Drink straw has been clinically shown to help strengthen the immune system. BOOST Kid Essentials Drink is perfect for children who are below growth percentiles, having trouble gaining weight, resisting eating enough nutritious foods, or needing extra nutrition to help maintain an active lifestyle.

But in December 2009, the FDA  issued a letter to the company warning it that it was marketing this product as a drug:

this product is misbranded under…the Federal Food, Drug, and Cosmetic Act… because the label is false or misleading in that the product is labeled and marketed as a medical food but does not meet the statutory definition of a medical food in the Orphan Drug Act…Furthermore, this product is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Act…The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.

The warning letter didn’t get into the business of whether probiotics really do any good (the European Food Safety Authority certainly doesn’t think so) or whether “healthy” bacteria stay live and active in a straw stuck in the packaging of a kids’ drink.  The company must not have wanted to get into all that, so it settled.  The probiotic straw no longer comes with the package.

Nestlé is the largest food company in the world with earnings that exceed $100 billion annually.  It should have known better.

Update, July 15: Since the FTC imposed no penalties on Nestlé,  analysts expect class action lawsuits to follow in due course.  And here’s the account in the New York Times (I’m quoted).