Effect of Nutrition Ingredients on Microbiota Modulation

Healthy Volunteers Clinical Trial

— VitaGut  

Official title:

A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668964
• Other study ID #: 2017-12-19-VIT
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: March 2020
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Vitamin B2
One capsule of 75 mg Vitamin B2 once a day for 4 weeks
• Vitamin C
One capsule of 500 mg Vitamin C once a day for 4 weeks
• Vitamin B2 + C
One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks
• Vitamin A
One capsule of 250 µg Vitamin A once a day for 4 weeks
• Vitamin D3
One capsule of 60 µg Vitamin D3 once a day for 4 weeks
• Vitamin E
One capsule of 100 mg Vitamin E once a day for 4 weeks
• Placebo
One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks

Locations

Country	Name	City	State
Ireland	Atlantia	Cork	Blackpool Cork

Sponsors (2)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electronic Gastrointestinal Symptom Rating Scale (GSRS) questionnaire	Changes from baseline in the treatment groups as compared to placebo of the GSRS. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms	from baseline to 4 weeks
Other	Short Form 36 (SF-36) questionnaire	Changes from baseline in the treatment groups as compared to placebo of the quality of life questionnaire Short Form 36 (SF-36) questionnaire. The Short Form (SF)-36 generates a profile of health-related quality of life outcomes by measuring health across eight different dimensions: physical functioning, role limitation because of physical health, social functioning, vitality, bodily pain, mental health, role limitation because of emotional problems and general health. Responses to each question within a dimension are combined to generate a score from 0 to 100; where 100 indicates "good health".	from baseline to 4 weeks
Other	Volatile organic compound levels in fecal samples	Changes from baseline in the treatment groups as compared to placebo of volatile organic compounds (intensity)	from baseline to 4 weeks
Primary	Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing	Changes from baseline in the treatment groups as compared to placebo of relative abundance of microbial taxa (operational taxonomic units)	from baseline to 4 weeks
Secondary	Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing	Changes from baseline in the treatment groups as compared to placebo of alpha diversity assessed with shotgun sequencing (Shannon diversity, Estimated ChaoI index)	from baseline to 4 weeks
Secondary	Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing	Changes from baseline in the treatment groups as compared to placebo of beta diversity assessed with shotgun sequencing (bray-curtis distance metrics)	from baseline to 4 weeks
Secondary	Short-chain fatty acids concentrations in fecal samples	Changes from baseline in the treatment groups as compared to placebo of short-chain fatty acids using GC-MS (mM)	from baseline to 4 weeks
Secondary	Ammonia concentrations in fecal samples	Changes from baseline in the treatment groups as compared to placebo of ammonia concentrations assessed with phenol-hypochlorite method (mg/L)	from baseline to 4 weeks
Secondary	Cytokines and chemokines in blood	Changes from baseline in the treatment group as compared to placebo of cytokines and chemokines using immune assays (pg/mL)	from baseline to 4 weeks