NCT03668964

Effect of Nutrition Ingredients on Microbiota Modulation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-08-20
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2018-09-13
• Last updated: 2020-03-30

Locations

1 site across 1 country: Ireland