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Completed

NCT Number: NCT02224365

The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women (1 to 10 years postmenopausal)
  • Aged 45-65 years
  • Prediabetes or Type 2 Diabetes (Hemoglobin A1c ≥ 5.7%)
  • Overweight or obese (body mass index between 25 and 40 kg/m2)

Exclusion criteria

  • Diagnosed cardiovascular disease
  • Uncontrolled hypertension (≥ 160/100 mmHg)
  • Other active chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
  • Participating in a weight loss program
  • Heavy smokers (> 20 cigarettes per day)
  • Heavy drinkers (> 12 alcoholic drinks per week)
  • Consumption of more than two apples per week
  • Body mass index less than 25 or greater than 40 kg/m2)

Treatment and study plan

Apple

Dietary Supplement

12 weeks of 75 g dried apple powder taken in 480 ml per day.

Placebo

Dietary Supplement

12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.

Primary outcomes

  1. Blood Pressure

    Time frame: 12 weeks

    By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

Secondary outcomes

  1. Arterial Stiffness

    Time frame: 12 weeks

    By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

  2. Autonomic Control of Blood Pressure

    Time frame: 12 weeks

    By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.

  3. Endothelial-mediated Vasodilation

    Time frame: 12 weeks

    By measuring flow-mediated dilation in the brachial artery.

  4. Inflammation

    Time frame: 12 weeks

    By measuring markers of inflammation.

  5. Oxidative Stress

    Time frame: 12 weeks

    By measuring markers of oxidative stress.

  6. Insulin Sensitivity

    Time frame: 12 weeks

    By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.

  7. Atherogenic Markers

    Time frame: 12 weeks

    By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.

  8. Body Composition

    Time frame: 12 weeks

    By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • U.S. Apple Association

Registry information

Official study title

Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 25, 2014
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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