Effect of Nutrition Ingredients on Microbiota Modulation

NCT03668964 | Completed

• 1 other identifier: 2017-12-19-VIT
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Intestinal microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing

  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

• Short-chain fatty acids concentrations in fecal samples

  from baseline to 4 weeks

• Ammonia concentrations in fecal samples

  from baseline to 4 weeks

• Cytokines and chemokines in blood

  from baseline to 4 weeks

Other Outcomes (3)

• Electronic Gastrointestinal Symptom Rating Scale (GSRS) questionnaire

  from baseline to 4 weeks

• Short Form 36 (SF-36) questionnaire

  from baseline to 4 weeks

• Volatile organic compound levels in fecal samples

  from baseline to 4 weeks

Study Arms (7)

Vitamin B2

EXPERIMENTAL

Daily dose of 75 mg Vitamin B2

Dietary Supplement: Vitamin B2

Vitamin C

EXPERIMENTAL

Daily dose of 500 mg Vitamin C

Dietary Supplement: Vitamin C

Vitamin B2 + C

EXPERIMENTAL

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

Dietary Supplement: Vitamin B2 + C

Vitamin A

EXPERIMENTAL

Daily dose of 250 µg Vitamin A

Dietary Supplement: Vitamin A

Vitamin D3

EXPERIMENTAL

Daily dose of 60 µg Vitamin D3

Dietary Supplement: Vitamin D3

Vitamin E

EXPERIMENTAL

Daily dose of 100 mg Vitamin E

Dietary Supplement: Vitamin E

Placebo

PLACEBO COMPARATOR

Daily dose of 575 mg microcrystalline cellulose

Dietary Supplement: Placebo

Interventions

Vitamin B2 DIETARY_SUPPLEMENT

One capsule of 75 mg Vitamin B2 once a day for 4 weeks

Also known as: Riboflavin

Vitamin B2

Vitamin C DIETARY_SUPPLEMENT

One capsule of 500 mg Vitamin C once a day for 4 weeks

Vitamin C

Vitamin B2 + C DIETARY_SUPPLEMENT

One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks

Vitamin B2 + C

Vitamin A DIETARY_SUPPLEMENT

One capsule of 250 µg Vitamin A once a day for 4 weeks

Vitamin A

Vitamin D3 DIETARY_SUPPLEMENT

One capsule of 60 µg Vitamin D3 once a day for 4 weeks

Also known as: Cholecalciferol

Vitamin D3

Vitamin E DIETARY_SUPPLEMENT

One capsule of 100 mg Vitamin E once a day for 4 weeks

Also known as: alpha-tocopherol

Vitamin E

Placebo DIETARY_SUPPLEMENT

One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia

Cork, Blackpool Cork, T12HH60, Ireland

Location

Related Publications (1)

• 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.

  PMID: 33615992 DERIVED

MeSH Terms

Interventions

Riboflavin; Ascorbic Acid; Vitamin A; Cholecalciferol; Vitamin E; alpha-Tocopherol

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Tocopherols

Study Officials

• Timothy Dinan, Prof

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel trial

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: September 13, 2018
• Study Start: August 20, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)