Clinical trial NCT03668964: Effect of Nutrition Ingredients on Microbiota Modulation
Official title: A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Intestinal microbiota
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2018-09-13
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel trial
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
timeFrame: from baseline to 4 weeks
Secondary outcomes:
measure: Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
timeFrame: from baseline to 4 weeks
measure: Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
timeFrame: from baseline to 4 weeks
measure: Short-chain fatty acids concentrations in fecal samples
timeFrame: from baseline to 4 weeks
measure: Ammonia concentrations in fecal samples
timeFrame: from baseline to 4 weeks
measure: Cytokines and chemokines in blood
timeFrame: from baseline to 4 weeks
Other outcomes:
measure: Electronic Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
timeFrame: from baseline to 4 weeks
measure: Short Form 36 (SF-36) questionnaire
timeFrame: from baseline to 4 weeks
measure: Volatile organic compound levels in fecal samples
timeFrame: from baseline to 4 weeks
Locations:
city: Cork
country: Ireland
facility: Atlantia
state: Blackpool Cork
Study officials:
affiliation: Cork University Hospital
name: Timothy Dinan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pham VT, Fehlbaum S, Seifert N, Richard N, Bruins MJ, Sybesma W, Rehman A, Steinert RE. Effects of colon-targeted vitamins on the composition and metabolic activity of the human gut microbiome- a pilot study. Gut Microbes. 2021 Jan-Dec;13(1):1-20. doi: 10.1080/19490976.2021.1875774.