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

Completed · Not applicable

Conditions studied: Digestive Health and Immune Function

In brief

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.

Key facts

Study ID

NCT01902394

Run by

Tufts University

People needed

108

Starts

2012-06-01

Expected to finish

2014-09-01

Last updated by the study team

2015-05-21

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Self reported weight change >4kg within the past 3 months.
• Have participated in a weight loss program within the last 3-months; eligible if in weight reduction program to maintain body weight.
• Not willing to reduce habitual daily fiber intake (including prebiotics) within 2 wk prior to enrollment to < \~7g/1000kcal/d for men, or <\~8g/1000kcal/d for women if currently consuming greater amounts.
• Not willing to stop consumption of probiotic or prebiotic supplements within 2 weeks prior to start of study if currently taking these, as well as during study participation.
• Vegetarian diet.
• Not willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), including fish oil or n-3 fatty acids and herbal supplements, for 30 days prior to or during study participation, if currently taking these.
• Regular use of laxatives, stool softeners, or anti-diarrheal medications, and medications influencing food intake and/or appetite.
• Not willing to undergo a 3-month washout period after colonoscopy prior to enrollment, and not willing to defer colonoscopy until after study completion.
• Eating disorder within the past 10 years.
• Disinhibited eating behavior as indicated by a score above 12 on the Three Factor Eating Questionnaire.
• Food allergies or aversions or other issues with foods that would preclude use of study diets, including gluten, milk, nuts, or eggs.
• Individuals identified during screening as having barriers expected to deter compliance with dietary requirements (e.g., stated dislike of study foods, inadequate resources to store and reheat meals, inability to adhere to food pick-up schedule).
• Alcohol consumption >2 drinks per day.
• Not willing to abstain from alcohol consumption during the study.
• Smoking or using nicotine containing products in the last 6 months.
• Use of aspirin, non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or the inability to discontinue the use of these substances for 72 hrs before first day blood draw until 48 hrs after DTH implant (i.e. after second reading).
• Use of anabolic steroids, insulin, growth hormone or testosterone.
• Type I or type II diabetes.
• Uncontrolled major illnesses. (Will include if stable on drugs used to control cardiovascular, liver, and renal diseases, asthma, and dysphagia).
• Current use of proton pump inhibitors and H2 blockers to control acid-reflux/heart burn
• Use of medications which interfere with energy metabolism including oral glycemic agents and insulin.
• Uncontrolled hypertension as determined by study physician or nurse.
• Use of immunosuppressive drugs.
• Active cancer or current cancer diagnosis (except non-melanoma skin cancer).
• Active infection within 2 weeks of study enrollment, blood draws or skin tests; however, may participate if admission is postponed or study activity is rescheduled > 2 weeks after resolution of symptoms.

Where it is running

• HNCRA at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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