NCT06611215

Effect of a Nutritional Supplement on Gut Microbiota in Adults

A Randomized, Double Blind, Placebo-controlled, Parallel Study to Investigate the Effect of Prebiotic Supplements on Gut Microbiota Modulation and Quality of Life.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Pharmavite LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

According to International Scientific Association for Probiotics and Prebiotics (ISAPP), a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit (Gibson et al, 2017). Fibers/ Prebiotics are known to have several beneficial effects on human health via gut. They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota. This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health. The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses.

Detailed description

This is a 4 arm randomized, placebo-controlled, double-blind, parallel study, which will be conducted remotely and will include 4 visits over 10 week period - a screening visit (Visit 1; week -2), a 2-week run-in period followed by baseline determination or baseline visit (Visit 2; day 0), and two test visits (Visits 3 and 4 at days 28, and 56 respectively). SCREENING Visit 1 - Week -2 At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out: * Participants will receive oral and written information about the study and be allowed to ask questions. * Participants will sign the informed consent document. * Inclusion and exclusion criteria will be reviewed. * Demographic, health, and lifestyle data will be collected. * Medical history will be collected. * Concomitant medication will be recorded. * Height and weight will be collected , Body Mass Index (BMI) calculated. * Complete Block Fiber screener Participants will be given an appointment to return to the study site within 14 days for their baseline/day 1 visit. INTERVENTION PHASE Visit 2 - Week 0 Participants will attend this study visit and the following procedures will be carried out: * Participant's continued consent to study procedures will be confirmed. * Inclusion/exclusion criteria will be reviewed. * Adverse events will be recorded. * Concomitant medication/supplements will be recorded. * Weight will be measured, and BMI calculated. * Participants will return their saliva samples and samples will be stored for future analysis. * Participants will return their stool sample and sample will be stored for future analysis. * Participants will have completed the following questionnaires within 24 hours of the visit: * 36 item short form survey (SF-36) Participants will be randomized into one of two treatment groups as follows, but will be blinded as to which group, they are in: * Group 1: Prebiotic 1 * Group 2: Placebo 1 * Group 3: Prebiotic 2 * Group 4: Placebo 2 Participants will be supplied with an 8-week supply of study product and instructions of dosing. Participants will be instructed to take one stick pack each day for the next eight weeks. An additional eight four days of doses will be supplied in case of delay of study visit or loss of study product. \- Participants will be provided with an appointment to return to the study site in four weeks. Visit 3 - Week 4 Participants will return for virtual visit: * Participant's continued consent to study procedures will be confirmed. * Adverse events will be recorded. * Concomitant medication/supplements will be recorded. * Weight will be measured, and BMI calculated. * Participants will return their saliva samples and samples will be stored for future analysis. * Participants will return their stool sample and sample will be stored for future analysis. * \- Participants will have completed the following questionnaires within 24 hours of the visit: * 36 item short form survey (SF-36) * Participants will be provided with an appointment to return to the study site in four weeks. Visit 4 (Final Visit) - Week 8 Participants will return to the study site at day 56 and the following procedures will be carried out: * Adverse events will be recorded. * Concomitant medication/supplements will be recorded. * Participants will return any unused study product and compliance will be assessed. * Participants will return their saliva samples and samples will be stored for future analysis. * Participants will return their stool sample and sample will be stored for future analysis. * Participants will return their 3-day food diary. * Weight will be measured, and BMI calculated. * Participants will have completed the following questionnaires within 24 hours of the visit: * 36 item short form survey (SF-36)

Conditions

• Changes in Gut Microbiota with Prebiotic Supplementation
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Treatment	Prebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning
DIETARY_SUPPLEMENT	Placebo	Placebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning
DIETARY_SUPPLEMENT	Treatment	Prebiotic 2 - Stick pack of combination 2 of two polysaccharides mixed with a glass of water each morning
DIETARY_SUPPLEMENT	Placebo	Placebo 2 - stick pack of maltodextrin 2 mixed with a glass of water each morning

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-04-07
• Completion: 2025-06-02
• First posted: 2024-09-24
• Last updated: 2024-09-24

Locations

1 site across 1 country: United States