An interventional study of Whole grains and Refined grains in Digestive Health and Immune Function, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.
Sponsored by Tufts University · Not applicable and Interventional
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.
This study is a randomized parallel-arm trial using a six-week dietary intervention following a 2 week run-in period. Healthy volunteers will be randomized to two groups (n=40/group), and consume either a diet rich in whole grains or a diet rich in refined grains provided at estimated energy requirements for 6 weeks. Outcomes will be measured during the run-in period and at week 6 of the intervention. To control for variation in microbiota an additional 10 volunteers will serve as "negative controls" and not undergo any diet intervention.
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Subjects Inclusion Criteria
Pass screening blood and urine tests
Exclusion Criteria
Participants in the whole grain (WG) group will receive a diet providing 100% of energy requirements in a diet rich in whole grains.
Other: Whole grains
Participants in the refined grain (RG) group will receive a diet providing 100% of energy requirements in a diet rich in refined grains.
Other: Refined grains
Subjects randomized to the negative control group will consume their own usual diet (i.e. not receive foods and beverages from the study).
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.
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.
change in T Cell-mediated immunity
Delayed-type hypersensitivity (DTH) and lymphocyte proliferation will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention to assess adaptive immune function, specifically T cell-mediated immunity.
Time frame: week 2 of washout diet and week 6 of diet intervention
change in Lymphocyte proliferation
Whole blood collected at baseline (week 2 of washout period) and at week-6 of the diet intervention will be investigated for the ability of lymphocytes to proliferate by quantifying the incorporation of tritium following mitogen stimulation.
Time frame: week 2 of washout diet and week 6 of diet intervention
change in Natural Killer Function
The ability of peripheral blood mononuclear cells to bind and kill leukemia cells will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention
Time frame: week 2 of washout diet and week 6 of diet intervention
change in Cytokines
Peripheral blood and stool samples will be analyzed at baseline (week 2 of washout diet) and week-6 of diet intervention for cytokines.
Time frame: week 2 of washout diet and week 6 of diet intervention
change in Salivary immunoglobulin A (IgA)
Salivary IgA will be analyzed at baseline (week 2 of washout period) and at week-6 of the diet intervention.
Time frame: week 2 of washout diet and week 6 of intervention diet
change in gut microbiota composition
Phylogenetic composition and relative abundance of bacteria in stool will be analyzed from 24-hour fresh sample collected at baseline (week 2 of washout diet) and at week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in cardiovascular health risk factors
Consumption of the whole grain (WG) diet will be beneficial for multiple outcomes of cardiovascular health including a favorable blood lipid profile (low density lipoprotein, very low-density lipoprotein, high density lipoprotein, total cholesterol and triglycerides), and a decrease in blood pressure, and in oxidative stress status (secondary hypothesis).
Time frame: week 2 of washout diet and week 6 of intervention diet
change in vitamin K status
Fecal menaquinones concentrations; Fasting serum phylloquinone and menaquinones concentration from 72-hour stool collected at baseline (week 2 of washout diet) and at week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in body composition
Fat and fat free mass; waist and hip circumference
Time frame: week 2 of washout diet and week 6 of intervention diet
change in appetite
Visual analog scales to assess hunger, fullness and satisfaction while on the study diet
Time frame: Weekly for 8 weeks
change in fasting gut hormone concentration
Plasma glucagon-like peptide-1 and peptide-YY will be measured from blood samples collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in fasting serum leptin
Time frame: week 2 of washout diet and week 6 of intervention diet
change in glycemic regulation
48 hr continuous glucose monitoring; fasting serum glucose; fasting serum insulin; HOMA-IR
Time frame: week 2 of washout diet and week 6 of intervention diet
change in resting energy metabolism
Resting energy expenditure; substrate oxidation at rest
Time frame: week 2 of washout diet and week 6 of intervention diet
change in eating behaviors
Questionnaires will be administered at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in quality of life
Questionnaires will be administered at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in breath hydrogen and methane
Time frame: week 2 of washout diet and week 6 of intervention diet
change in stool pH
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in 72hr fecal weight
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in stool water content
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in total stool anaerobic and aerobic bacterial counts
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in stool energy content
Will be measured from 72-hour stool sample collected at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in DNA methylation
Time frame: week 2 of washout diet and week 6 of intervention diet
change in concentrations of the cholesterol synthesis (squalene, desmosterol, lathosterol) and absorption (campesterol, sitosterol, cholestanol) markers
Plasma squalene, desmosterol, lathosterol), campesterol, sitosterol, and cholestanol concentrations will be measured at baseline (week 2 of washout diet) and week 6 of intervention diet
Time frame: week 2 of washout diet and week 6 of intervention diet
change in serum vitamin D
Time frame: week 2 of washout diet and week 6 of intervention diet
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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