Peanut Consumption and Cardiovascular Disease Risk in a Chinese Population
Condition: T2D
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Peanut; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary Supplement: Peanut; Dietary Supplement: High carbohydrate snacks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel design with two intervention arms
Masking: None (Open Label)
Primary purpose: Prevention