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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224365
• Other study ID #: RF02435
• Secondary ID: 2015.14930
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2014
• Last updated: December 6, 2016
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Prediabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Apple
12 weeks of 75 g dried apple powder taken in 480 ml per day.
• Placebo
12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.

Locations

Country	Name	City	State
United States	Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	U.S. Apple Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).	12 weeks	No
Secondary	Arterial Stiffness	By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).	12 weeks	No
Secondary	Autonomic Control of Blood Pressure	By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.	12 weeks	No
Secondary	Endothelial-mediated Vasodilation	By measuring flow-mediated dilation in the brachial artery.	12 weeks	No
Secondary	Inflammation	By measuring markers of inflammation.	12 weeks	No
Secondary	Oxidative Stress	By measuring markers of oxidative stress.	12 weeks	No
Secondary	Insulin Sensitivity	By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.	12 weeks	No
Secondary	Atherogenic Markers	By measuring adhesion factors, lipid profiles, and atherogenic risk ratios.	12 weeks	No
Secondary	Body Composition	By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.	12 weeks	No

External Links

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