T2D Clinical Trial
Official title:
Effects of Peanut Consumption on Cardiovascular Disease Risk Factors and Gut Microbiota Among Adults in China: A Randomized Controlled Trial
This is a 2 parallel-arm randomized controlled study with free-living subjects on
self-selected diets. The objective of this study is to compare the effects of two servings of
peanuts with an isocaloric matched refined carbohydrate snack food on glucose, lipids and
lipoproteins and cardiovascular health risk factors, satiety and gut microbiota in 250
Chinese participants at risk for metabolic syndrome (overweight/obese, enlarged waist
circumference, elevated LDL-cholesterol, prehypertension, and/or prediabetes).
The investigators hypothesize that the inclusion of 2 serving of peanuts in the diet will
decrease blood glucose, LDL-cholesterol, and improve satiety sanctification between meals and
gut microbiota compared to the control group and baseline.
Emerging evidence has shown that peanut consumption has beneficial effects in modifying lipid
profiles, glucose, and other cardiometabolic risk factors. During the last two decades, China
has experienced a dramatic increase in T2D prevalence largely due to rapid social and
economic growth. Peanuts are commonly consumed as snacks in China. However, there is limited
evidence on the specific health benefits of peanuts as part of the Chinese habitual diet.
Clinical Study Protocol
Study diet Subjects will consume their habitual diet with the test snacks provided as roasted
peanuts and rice flour snack bars twice a day during a mid- morning snack and mid -afternoon
snack. Subjects in the peanut group will consume two serving of peanuts and subjects in the
control group will consume isocaloric rice bars on a daily basis under on site supervision.
Subjects will be instructed to maintain their habitual diet and physical activity. During the
study period, body weight will be monitored routinely to ensure that baseline weight does not
fluctuate by more than 1kg. Prior to day 1, day 42 and day 84, a three-day diet record will
be administered to subjects to calculate basal energy intake.
Study design The study is a randomized, controlled, parallel-arm trial precedes by a 1-week
run-in period with control treatment to assess compliance, acceptability and to determine
baseline values.After the run-in period, participants will be randomized to either the
control group or treatment group for three months. Each treatment phase will be 3 months in
duration. At baseline, day 42 and day 84, clinical assessment (body weight, waist/hip
circumference, blood pressure, pulse) will be preformed and blood samples will be collected.
Urinary will be collected on baseline, day 42 and day 84. Fecal samples will be collected on
baseline and day 84. Three days dietary records and appetite sensation ratings will be
collected three times during the study (baseline, day 42 and day 84).
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