NCT03668964CompletedNot Applicable
A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults
DSM Nutritional Products, Inc.2 sites in 1 country96 target enrollmentStarted: August 20, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Study Overview
Brief Summary
The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;
- •Be between 20 and 50 years of age;
- •Has a BMI of between 18.5 - 30 Kg/m2;
- •Has a stable body weight (< 5% change) over the past 3-months;
- •Is in general good health, as determined by the investigator;
- •Willing to avoid consuming dietary supplements, prebiotic, probiotic, dietary or fibre rich supplements within 4 weeks prior to baseline visit, until the end of the study;
- •Willing to avoid liver consumption during the intervention
- •Maintain current level of physical activity;
- •Women of child-bearing potential using a non-hormonal contraceptive (e.g. IUD);
- •Willing to consume the investigational product daily for the duration of the study.
Exclusion Criteria
- •Females are pregnant, lactating or wish to become pregnant during the study.
- •Are hypersensitive to any of the components of the test product;
- •Has taken antibiotics within the previous 3 months;
- •Has a history of drug and/or alcohol abuse at the time of enrolment;
- •Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
- •Is a smoker;
- •Has made any major dietary changes in the past 3 months;
- •Subject is planning a sun or ski holiday over the duration of the study;
- •Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
- •Has an eating disorder;
- •Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
- •Is using fibre supplements or enemas;
- •Has a high fiber diet (i.e. >30 g) based on FFQ;
- •Has an active gastrointestinal disorder or previous gastrointestinal surgery,
- •If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months prior to screening and agree to maintain the same dosage throughout the study;
- •Has a metabolic, psychiatric, or gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, cancer, etc.), with a history of such diseases;
- •Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
- •Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
- •Have a malignant disease or any concomitant end-stage organ disease;
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
- •Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
Outcomes
Primary Outcomes
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of relative abundance of microbial taxa (operational taxonomic units)
Secondary Outcomes
- Cytokines and chemokines in blood(from baseline to 4 weeks)
- Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing(from baseline to 4 weeks)
- Ammonia concentrations in fecal samples(from baseline to 4 weeks)
- Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing(from baseline to 4 weeks)
- Short-chain fatty acids concentrations in fecal samples(from baseline to 4 weeks)
Investigators
Study Sites (2)
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