Whole Grain and Fiber Addition Study

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT03623308

Collaborator

General Mills (Industry)

Enrollment

Location

Arms

9.9

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The human gut microbiota is the complex community of bacteria that reside within the human gastrointestinal tract. This community plays an important role in supporting normal immune function and digestion. Disruption of the microbial communities within the gastrointestinal tract, sometimes termed "dysbiosis" is linked to a wide range of human diseases, including obesity, metabolic syndrome, malnutrition, and cancer. Stability of the microbiome is thought to be important for human health, however the factors that drive microbiome community stability are poorly understood.

Within the gastrointestinal tract, the microbiota is constantly exposed to complex mixtures of foods and the products of digestion. Importantly, changes in diet have been shown to rapidly induce shifts in microbial community composition. These compositional shifts can also affect microbial production of bioactive metabolites, which may be one mechanism to explain how the microbiome impacts host physiology and disease.

Fiber is often considered to be one of the largest contributors to microbial compositional shifts that follow dietary interventions. Fiber resists digestion and persists through the gastrointestinal tract to reach the large intestine where it can be metabolized by bacteria. The end products of this metabolism are the short chain fatty acids (SCFAs), acetate and butyrate, which are often associated with beneficial health outcomes. Fibrous foods are also a source of polyphenols and other phenolic compounds that may be used by microbes in the production of secondary metabolites or freed from the food matrix by microbial enzymes.

The purpose of this study is to: 1) to investigate the impact of high fiber, whole grain and bran cereal on microbiome stability, and 2) to explore the microbial contribution to polyphenol metabolism from whole grain in healthy individuals.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Fiber cereal	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Microbiome Stability After Addition of a High Fiber, Whole Grain and Bran Cereal to the Diets of Healthy Individuals

Actual Study Start Date :

May 4, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fiber Intervention I Participants will be asked to consume two ½ cup servings of fiber cereal daily (equivalent to 28 g fiber) for 14 days, one in the morning and one in the evening.	Other: Fiber cereal Whole grain and bran cereal
Experimental: Fiber Intervention II Participants will be asked to consume two ¼ cup servings of fiber cereal daily (equivalent to 14 g fiber) for 14 days, one in the morning and one in the evening.	Other: Fiber cereal Whole grain and bran cereal

Arm

Intervention/Treatment

Experimental: Fiber Intervention I

Participants will be asked to consume two ½ cup servings of fiber cereal daily (equivalent to 28 g fiber) for 14 days, one in the morning and one in the evening.

Other: Fiber cereal

Whole grain and bran cereal

Experimental: Fiber Intervention II

Participants will be asked to consume two ¼ cup servings of fiber cereal daily (equivalent to 14 g fiber) for 14 days, one in the morning and one in the evening.

Other: Fiber cereal

Whole grain and bran cereal

Outcome Measures

Primary Outcome Measures

Change in microbiome stability [Change from baseline to 6 weeks]
Shotgun metagenomic sequencing of stool samples

Secondary Outcome Measures

Microbiome functional capacity [Baseline, 2 weeks, 6 weeks]
Assessment of microbiome functional capacity using DNA alignment to KEGG orthology
Urinary metabolome [Baseline, 2 weeks, 6 weeks]
Targeted liquid chromatography mass spectroscopy to detect urinary metabolites
Fecal short chain fatty acids [Baseline, 2 weeks, 6 weeks]
Targeted liquid chromatography mass spectroscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy adults over 18 years
BMI between 18 and 30
English speaker with ability to use a computer/smartphone.

Exclusion Criteria:

Women who are currently pregnant or breastfeeding
Current use of antibiotics or use of antibiotics within the last month
Self-reported, pre-existing history of gastrointestinal disease including IBD, IBS, Crohn's disease, Celiac disease (or self-reported sensitivity to gluten), history of bowel blockage/impacted stool, fecal incontinence, gastroparesis or diverticulosis.
Type I/II diabetes mellitus
Participants actively trying to lose weight
Chronic use of antacids and/or laxatives
Use of seizure disorder medications or tricyclic antidepressants
Consumption of drugs or supplements related to energy intake (i.e. diet pills and appetite suppressants)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota
General Mills

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT03623308

Other Study ID Numbers:

STUDY00002230

First Posted:

Aug 9, 2018

Last Update Posted:

Nov 1, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 1, 2019