Whole Grain and Fiber Addition Study

NCT03623308 | Completed

• 1 other identifier: STUDY00002230
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in microbiome stability

  Shotgun metagenomic sequencing of stool samples

  Change from baseline to 6 weeks

Secondary Outcomes (3)

• Microbiome functional capacity

  Baseline, 2 weeks, 6 weeks

• Urinary metabolome

  Baseline, 2 weeks, 6 weeks

• Fecal short chain fatty acids

  Baseline, 2 weeks, 6 weeks

Study Arms (2)

Fiber Intervention I

EXPERIMENTAL

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

Fiber Intervention II

EXPERIMENTAL

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

Interventions

Fiber cereal OTHER

Whole grain and bran cereal

Fiber Intervention I; Fiber Intervention II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead
• General Mills: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: August 9, 2018
• Study Start: May 4, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)