Effect of Nutrition Ingredients on Microbiota Modulation (VitaGut)

DSM Nutritional Products

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin E; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin B2 + C; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin B2; Dietary Supplement: Vitamin A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03668964

2017-12-19-VIT

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;
2. Be between 20 and 50 years of age;
3. Has a BMI of between 18.5 - 30 Kg/m2;
4. Has a stable body weight (< 5% change) over the past 3-months;
5. Is in general good health, as determined by the investigator;
6. 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;
7. Willing to avoid liver consumption during the intervention
8. Maintain current level of physical activity;
9. Women of child-bearing potential using a non-hormonal contraceptive (e.g. IUD);
10. Willing to consume the investigational product daily for the duration of the study.

Exclusion criteria

1. Females are pregnant, lactating or wish to become pregnant during the study.
2. Are hypersensitive to any of the components of the test product;
3. Has taken antibiotics within the previous 3 months;
4. Has a history of drug and/or alcohol abuse at the time of enrolment;
5. Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
6. Is a smoker;
7. Has made any major dietary changes in the past 3 months;
8. Subject is planning a sun or ski holiday over the duration of the study;
9. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
10. Has an eating disorder;
11. Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
12. Is using fibre supplements or enemas;
13. Has a high fiber diet (i.e. >30 g) based on FFQ;
14. Has an active gastrointestinal disorder or previous gastrointestinal surgery,
15. 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;
16. 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;
17. Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
18. Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
19. Have a malignant disease or any concomitant end-stage organ disease;
20. 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;
21. 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 7 patient groups, including a placebo group

Vitamin B2

Experimental group

Description:

Daily dose of 75 mg Vitamin B2

Treatment:

Dietary Supplement: Vitamin B2

Vitamin C

Experimental group

Description:

Daily dose of 500 mg Vitamin C

Treatment:

Dietary Supplement: Vitamin C

Vitamin B2 + C

Experimental group

Description:

Daily dose of 75 mg Vitamin B2 and 500 mg Vitamin C

Treatment:

Dietary Supplement: Vitamin B2 + C

Vitamin A

Experimental group

Description:

Daily dose of 250 µg Vitamin A

Treatment:

Dietary Supplement: Vitamin A

Vitamin D3

Experimental group

Description:

Daily dose of 60 µg Vitamin D3

Treatment:

Dietary Supplement: Vitamin D3

Vitamin E

Experimental group

Description:

Daily dose of 100 mg Vitamin E

Treatment:

Dietary Supplement: Vitamin E

Placebo

Placebo Comparator group

Description:

Daily dose of 575 mg microcrystalline cellulose

Treatment:

Dietary Supplement: Placebo