A Randomized, Double Blind, Placebo-controlled, Parallel Study to Investigate the Effect of Prebiotic Supplements on Gut Microbiota Modulation and Quality of Life.
Pharmavite LLC
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.
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 t…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: To be eligible for inclusion, the Participant must fulfil all the following criteria: 1. Be able to give written informed consent. 2. Be between 18-60 years inclusive. 3. BMI between 18.5 - 29.9kg/m2 4. Is in general good health, as determined by the investigator. 5. Consume less than 18g fiber per day. 6. Maintain current dietary habits and physical activity levels. 7. Willing to consume the Study Product for the duration of the study. Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. Participants who are p…
Interventions
- Dietary SupplementTreatment
Prebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning
- Dietary SupplementPlacebo
Placebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning
- Dietary SupplementTreatment
Prebiotic 2 - Stick pack of combination 2 of two polysaccharides mixed with a glass of water each morning
- Dietary SupplementPlacebo
Placebo 2 - stick pack of maltodextrin 2 mixed with a glass of water each morning
Location
- Atlantia Clinical Trials, 142 E Ontario StChicago, Illinois