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

NCT02224365 | Completed Phase 2

• 2 other identifiers: RF024352015.14930
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Cardiovascular Diseases; Prediabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

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

  12 weeks

Secondary Outcomes (8)

• Arterial Stiffness

  12 weeks

• Autonomic Control of Blood Pressure

  12 weeks

• Endothelial-mediated Vasodilation

  12 weeks

• Inflammation

  12 weeks

• Oxidative Stress

  12 weeks

Study Arms (2)

Apple

EXPERIMENTAL

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

Dietary Supplement: Apple

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Apple DIETARY_SUPPLEMENT

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

Apple

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead
• U.S. Apple Association: collaborator

Study Sites (1)

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

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bahram H. Arjmandi, PhD, RD

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

  PRINCIPAL INVESTIGATOR

• Arturo Figueroa, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Sarah A. Johnson, PhD, RDN

  Department of Food Science and Human Nutrition, Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Margaret A. Sitton Professor

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)