The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics
Condition: Diabetes; Cardiovascular Diseases; Prediabetes
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this study is that the daily consumption of 75 g dried apple powder for
      twelve weeks will improve arterial stiffness and blood pressure by improving
      endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering
      biochemical markers associated with cardiovascular risk and glycemic control compared to a
      macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with
      prediabetes or type 2 diabetes who are overweight or obese will be included in the study.
      After a two-week run-in phase, eligible men and women will be randomly assigned to one of two
      treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve
      weeks. After an initial telephone screening, all participants will be requested to report to
      the study site for their first visit. On the first visit (screening), participants will be
      provided with verbal and written explanation of the project. They will then be asked to sign
      an informed consent form, followed by measuring fasting glucose levels and a medical history
      questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be
      performed for medical history, medication use, dietary intake, and physical activity.
      Qualified participants will be scheduled for their second visit two weeks later (actual
      baseline data collection) and randomly assigned to their treatment group. On the second
      (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function
      will be measured followed by blood draw and urine collection. Anthropometrics will be
      measured. Participants will be provided with their assigned treatment and will receive
      standard instructions on how to fill out daily diaries for their treatment, and for food and
      physical activity records. Blood pressure, vascular function, blood draw, urine collection,
      and anthropometric, body composition, diet, and physical activity assessments will be
      repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular
      measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled
      room in the supine position after an overnight fast and 12 hours after the abstinence of
      caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.
    


Intervention name(s): Apple; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 12 weeks of 75 g dried apple powder taken in 480 ml per day.; 12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes; Arterial Stiffness; Blood Pressure; Endothelial Function; Body Composition; Glycemic Control; Apples; Functional Foods; Polyphenols; Fiber