Whole Grain and Fiber Addition Study

NCT ID: NCT03623308

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-04
• Study Completion Date: 2019-03-01

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fiber cereal

Intervention Type: OTHER

Whole grain and bran cereal

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.

Group Type: EXPERIMENTAL

Fiber cereal

Intervention Type: OTHER

Whole grain and bran cereal

Interventions

Fiber cereal

Whole grain and bran cereal

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Mills

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

STUDY00002230

Identifier Type: -

Identifier Source: org_study_id