SuperHMO Prebiotic for Gut Health

Overseen By Kim Sukhum, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Seeding, Inc DBA Tiny Health

Must not be taking: Prebiotics, Probiotics

Disqualifiers: Pregnancy, IBD, Celiac's, HIV, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken prebiotic or probiotic supplements in the last 6 months and must not take them during the study.

What data supports the effectiveness of the treatment SuperHMO for gut health?

Research shows that prebiotics, like those in SuperHMO, can help promote the growth of beneficial gut bacteria, which may improve gut health. Some studies suggest prebiotics can alleviate constipation and support overall gastrointestinal well-being. ^{1 2 3 4 5}

Is SuperHMO Prebiotic safe for human consumption?

Prebiotics, including those similar to SuperHMO, are generally considered safe for human consumption with a very low risk of serious side effects. Studies show that prebiotics like fructo-oligosaccharides and xylooligosaccharides are well tolerated in healthy adults, even at higher doses, without significant gastrointestinal issues. ^{1 6 7 8 9}

How does the SuperHMO treatment differ from other treatments for gut health?

SuperHMO is a prebiotic treatment that works by selectively promoting the growth of beneficial bacteria already present in the gut, unlike probiotics which introduce new bacteria. This approach can lead to a more stable and long-lasting improvement in gut health by enhancing the natural microbiota balance. ^{1 2 4 8 10}

What is the purpose of this trial?

The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome. Over the course of 30 days, intervention participants will take SuperHMO prebiotic formulation daily. Control participants will take a placebo daily. We will measure all participants\' gut microbiome using a gut health test before taking SuperHMO prebiotic or placebo and after 30 days of taking the supplement. We hypothesize that taking the SuperHMO prebiotic will improve gut health measurements such as the potential to produce short-chain fatty acids.

Eligibility Criteria

This trial is for healthy adults interested in participating in a study to evaluate the effects of a prebiotic supplement on gut health. Participants will be required to take a daily supplement or placebo and undergo gut health testing before and after the 30-day period.

Exclusion Criteria

Participants must not be pregnant or breastfeeding or trying to conceive within the study period.

I do not have any pre-existing gut conditions like IBD, Celiac's, Crohn's disease, or SIBO.

I haven't received at-home stool test results in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the SuperHMO prebiotic formulation or placebo daily for 30 days

4 weeks

Baseline visit for initial survey and microbiome sample, exit visit for final survey and microbiome sample

Follow-up

Participants are monitored for changes in gut microbiome diversity and health markers after treatment

4 weeks

Treatment Details

Interventions

• SuperHMO

Trial Overview The study is testing Layer Origin's SuperHMO prebiotic formulation against a placebo (non-GMO corn Maltodextrin). The main goal is to see if SuperHMO improves gut microbiome health, specifically its ability to produce beneficial short-chain fatty acids over 30 days.

Participant Groups

Group I: Intervention - SuperHMO Experimental Treatment 1 Intervention

The investigation product is commercially available and is marketed as SuperHMO Prebiotic Mix with 5 HMOs. This product is a dietary supplement which contains five major types of human milk oligosaccharides includes 2'-Fucosyllactose (2'-FL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), 6'-Sialyllactose (6'SL), and 3'-Sialyllactose (3'SL). SuperHMO is designed to boost the number and variety of beneficial bacteria in the gut by feeding them with five different kinds of human milk oligosaccharide prebiotics. This product does not contain any flavoring, colorants, preservatives or fillers. Each bottle contains 118 grams of the mix, 28 servings, with 4.2 grams per serving (2 scoops). Study participants will be instructed to take 1 scoop (2.1 g) per day for the first five days and increase to 2 scoops (4.2g) per day for days 6-30, the formulation can be dissolved in their beverage of choice and taken at any time of the day, with or without food.

Group II: Control Placebo Group 1 Intervention

Control participants will receive a commercially available maltodextrin, NOW Sports Nutrition, Non-GMO corn Maltodextrin, Rapid Absorption. The composition and absorption properties are similar to the investigational product and will be given in the same dosage (2.1g/day for days 1-5 and increasing to 4.2 g/day for days 6-30) and route of administration as the investigational product. The use of maltodextrin as a comparator in prebiotic supplementation in human trials is well-documented.

Who Is Running the Clinical Trial?

Seeding, Inc DBA Tiny Health

Lead Sponsor

Trials

2

Recruited

130+

Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)

Collaborator

Trials

1

Recruited

30+

Findings from Research

Prebiotics, particularly inulin-type fructans, are non-digestible ingredients that can selectively promote the growth of beneficial gut bacteria, which may improve health outcomes.

To truly understand the prebiotic effects, it's essential to study their impact on the entire gut microbiota in human subjects, rather than just focusing on individual bacteria in isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics: preferential substrates for specific germs? Roberfroid, MB.[2018]

Probiotics and prebiotics have been traditionally consumed for their health benefits, particularly for gut health, and there is growing scientific interest in the gut microbiota's role in health and disease.

While some human diseases, such as diarrheal illnesses and inflammatory bowel diseases, may benefit from probiotics, there is still a lack of extensive clinical evidence supporting their use, especially for prebiotics, which have not been widely tested in large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. Quigley, EM.[2022]

In a study using fecal cultures from healthy and morbidly obese adults, different prebiotics were tested, revealing that 1-kestose had the most significant impact on gut microbiota composition and metabolic activity.

Prebiotic modulation led to increased Bacteroides and Faecalibacterium in obese individuals, while normal-weight individuals showed higher levels of Bifidobacterium and Faecalibacterium, highlighting the need for tailored prebiotic treatments based on individual microbiota profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. Nogacka, AM., Salazar, N., Arboleya, S., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prebiotics: preferential substrates for specific germs? [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. [2022]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Modulation of the human gut microflora towards improved health using prebiotics--assessment of efficacy. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Nutritional advantages of probiotics and prebiotics. [2017]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Gastrointestinal Tolerance of Short-Chain Fructo-Oligosaccharides from Sugar Beet: An Observational, Connected, Dose-Ranging Study in Healthy Volunteers. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Shotgun Metagenomic Sequencing Revealed the Prebiotic Potential of a Fruit Juice Drink with Fermentable Fibres in Healthy Humans. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Prebiotics in the Infant Microbiome: The Past, Present, and Future. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Xylooligosaccharide increases bifidobacteria but not lactobacilli in human gut microbiota. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. [2022]