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

NCT ID: NCT02224365

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Cardiovascular Diseases Prediabetes

Keywords

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Diabetes Arterial Stiffness Blood Pressure Endothelial Function Body Composition Glycemic Control Apples Functional Foods Polyphenols Fiber

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Apple

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

Group Type EXPERIMENTAL

Apple

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Apple

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Apple Association

UNKNOWN

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Bahram Arjmandi

Margaret A. Sitton Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bahram H. Arjmandi, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

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

Arturo Figueroa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Food and Exercise Sciences, Florida State University

Sarah A. Johnson, PhD, RDN

Role: PRINCIPAL_INVESTIGATOR

Department of Food Science and Human Nutrition, Colorado State University

Locations

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

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2015.14930

Identifier Type: OTHER

Identifier Source: secondary_id

RF02435

Identifier Type: -

Identifier Source: org_study_id