The Addition of Whole Grains to the Diets of Adults: A Study of Digestive Health and Natural Defenses

Summary

The purpose of this study is to determine if substituting whole grains for refined grains in the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria in the gut, and has beneficial effects on immune function, digestive health, cardiovascular health, regulation of body weight and composition, and vitamin K status.

The investigators hypothesize that whole grain consumption over a period of 6 weeks will alter the gut microflora toward a more beneficial bacterial profile, improve the immune response while reducing oxidative stress and inflammatory markers, have favorable effects on factors influencing the regulation of body weight and composition,increase bacterial vitamin K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption, vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is hypothesized that, consumption of whole grains will alter statin pharmacokinetics by decreasing rate of statin absorption, resulting in more sustained plasma concentrations.

Conditions

• Digestive Health and Immune Function

Interventions

OTHER

Whole grains

Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.

OTHER

Refined grains

Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.

Sponsors & Collaborators

• General Mills

  collaborator INDUSTRY

• Tufts Medical Center

  collaborator OTHER

• Tufts University

  lead OTHER

Principal Investigators

• Simin N Meydani, DVM, PhD · Human Nutrition Research Center on Aging

• Junaidah B Barnett, MCH(N), PhD · Human Nutrition Research Center on Aging

Study Design

Allocation

RANDOMIZED

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United States

Study Locations