Effect of Nutrition Ingredients on Microbiota Modulation
- Conditions
- Healthy Volunteers
- Interventions
- Dietary Supplement: Vitamin B2Dietary Supplement: Vitamin D3Dietary Supplement: Vitamin B2 + CDietary Supplement: Vitamin CDietary Supplement: Vitamin ADietary Supplement: Vitamin EDietary Supplement: Placebo
- Registration Number
- NCT03668964
- Lead Sponsor
- DSM Nutritional Products, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin B2 Vitamin B2 Daily dose of 75 mg Vitamin B2 Vitamin D3 Vitamin D3 Daily dose of 60 µg Vitamin D3 Vitamin B2 + C Vitamin B2 + C Daily dose of 75 mg Vitamin B2 and 500 mg Vitamin C Vitamin C Vitamin C Daily dose of 500 mg Vitamin C Vitamin A Vitamin A Daily dose of 250 µg Vitamin A Vitamin E Vitamin E Daily dose of 100 mg Vitamin E Placebo Placebo Daily dose of 575 mg microcrystalline cellulose
- Primary Outcome Measures
Name Time Method Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing 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 Outcome Measures
Name Time Method Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing from baseline to 4 weeks Changes from baseline in the treatment groups as compared to placebo of beta diversity assessed with shotgun sequencing (bray-curtis distance metrics)
Ammonia concentrations in fecal samples from baseline to 4 weeks Changes from baseline in the treatment groups as compared to placebo of ammonia concentrations assessed with phenol-hypochlorite method (mg/L)
Cytokines and chemokines in blood from baseline to 4 weeks Changes from baseline in the treatment group as compared to placebo of cytokines and chemokines using immune assays (pg/mL)
Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing from baseline to 4 weeks Changes from baseline in the treatment groups as compared to placebo of alpha diversity assessed with shotgun sequencing (Shannon diversity, Estimated ChaoI index)
Short-chain fatty acids concentrations in fecal samples from baseline to 4 weeks Changes from baseline in the treatment groups as compared to placebo of short-chain fatty acids using GC-MS (mM)
Trial Locations
- Locations (1)
Atlantia
🇮🇪Cork, Blackpool Cork, Ireland