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Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome

NCT03058575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-23

No results posted yet for this study

Summary

This is a randomized, 2-period crossover study aimed at assessing the effect of taking a food supplement containing a blend of microbial accessible carbohydrates on the diversity of the gut microbiome. Impacts to the skin, scalp and oral microbiomes; blood inflammatory biomarkers; quality and quantity of sleep; gastrointestinal quality of life; bowel habits, and facial skin features will also be evaluated.

Conditions

  • Gut Microbiome

Interventions

DIETARY_SUPPLEMENT

Dietary MACs

All subjects will have a dose-escalation period when randomized to the active arm that will occur as follows: Day 1: 1 scoop of product (morning, in the clinic) Day 2: 1 scoop of product (morning) Day 3: 2 scoops of product (morning and evening) Day 4: 2 scoops of product (morning and evening) Days 5-60: 3 scoops of product (morning, afternoon, evening) Other Names: Dietary fiber supplement

OTHER

Control

No Intervention for 8 weeks

Sponsors & Collaborators

  • Access Business Group

    lead INDUSTRY

Principal Investigators

  • Andrea Lawless, MD · Biofortis Innovation Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2017-07-11
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058575 on ClinicalTrials.gov