Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
Tallahassee, Florida, 32306, United States
NCT Number: NCT02224365
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.
Looking for future studies?
Notify Me45 year–65 year
All sexes
Interventional
Phase 2
Tallahassee, Florida, 32306, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 weeks
By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time frame: 12 weeks
By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time frame: 12 weeks
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
Time frame: 12 weeks
By measuring flow-mediated dilation in the brachial artery.
Time frame: 12 weeks
By measuring markers of inflammation.
Time frame: 12 weeks
By measuring markers of oxidative stress.
Time frame: 12 weeks
By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.
Time frame: 12 weeks
By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.
Time frame: 12 weeks
By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.
Florida State University
Other
Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics
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