Effect of a Nutritional Supplement on Gut Microbiota in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPharmavite LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be able to give written informed consent.
Be between 18-60 years inclusive.
BMI between 18.5 - 29.9kg/m2
Is in general good health, as determined by the investigator.
Disqualifiers
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: a. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
Participants who are on anxiolytics, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication at the time of screening.
Participants with a current or history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
Trial design
Design model
Parallel
Treatments tested in this trial
Treatment
Dietary supplementPrebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning
Placebo
Dietary supplementPlacebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning
Treatment
Dietary supplementPrebiotic 2 - Stick pack of combination 2 of two polysaccharides mixed with a glass of water each morning
Placebo
Dietary supplementPlacebo 2 - stick pack of maltodextrin 2 mixed with a glass of water each morning
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Prebiotic 1Experimental treatment 1 intervention
Group B: Placebo 1Placebo comparator 1 intervention
Group C: Prebiotic 2Experimental treatment 1 intervention
Group D: Placebo 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the effect of eight weeks consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at the end of 8 week intervention
Change in gut microbiota composition defined by percentage abundances of microbes (determined by shotgun sequencing of fecal samples) from baseline to end of intervention (Day 56) in the two prebiotic supplements compared to the corresponding Placebo
Time frame
From baseline to Week 8Secondary outcomes
1
To evaluate the effect of consumption of two distinct Prebiotic supplements compared to respective Placebos on microbiota composition at Week 4
Change in gut microbiota composition defined by percentage abundances of microbes (determined by shotgun sequencing of fecal samples) from baseline to end of intervention (Day 28) in the two prebiotic supplements compared to the corresponding Placebo
Time frame
From baseline to week 42
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 4
Change in Quality-of-Life scores (measured by 36-Item Short Form Health Survey (SF-36 RAND)) from baseline to end of intervention (Day 28) in the two prebiotic supplements compared to the corresponding Placebo in healthy adult population. The 36-Item Short Form Health Survey is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions . These outcomes will be grouped as a physical component summary and a mental component summary. The norm data is 0-100, and the health-related quality of life increases as the scores increase
Time frame
From baseline to week 43
To evaluate the effect of consumption of Prebiotic supplements compared to respective Placebos on Quality of Life at Week 8
Change in Quality-of-Life scores (measured by 36-Item Short Form Health Survey (SF-36 RAND)) from baseline to end of intervention (Day 56) in the two prebiotic supplements compared to the corresponding Placebo in healthy adult population. The 36-Item Short Form Health Survey is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions . These outcomes will be grouped as a physical component summary and a mental component summary. The norm data is 0-100, and the health-related quality of life increases as the scores increase
Time frame
From baseline to Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pharmavite LLC
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Source ClinicalTrials.gov
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