Effect of Nutrition Ingredients on Microbiota Modulation

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

Interventions

DIETARY_SUPPLEMENT

Vitamin B2

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

DIETARY_SUPPLEMENT

Vitamin C

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

DIETARY_SUPPLEMENT

Vitamin B2 + C

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

DIETARY_SUPPLEMENT

Vitamin A

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

DIETARY_SUPPLEMENT

Vitamin D3

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

DIETARY_SUPPLEMENT

Vitamin E

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

• Atlantia Food Clinical Trials

  collaborator INDUSTRY

• DSM Nutritional Products, Inc.

  lead INDUSTRY

Principal Investigators

• Timothy Dinan, Prof · Cork University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-20

Primary Completion

2019-07-15

Completion

2019-07-15

Countries

• Ireland

Study Locations