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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02224365
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
U.S. Apple Association
Information provided by (Responsible Party):
Bahram Arjmandi, Florida State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Cardiovascular Diseases Prediabetes Dietary Supplement: Apple Dietary Supplement: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics
Study Start Date : August 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Apple
12 weeks of 75 g dried apple powder taken in 480 ml per day.
 Dietary Supplement: Apple
12 weeks of 75 g dried apple powder taken in 480 ml per day.
Placebo Comparator: Placebo
12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.
 Dietary Supplement: Placebo
12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224365


Locations
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United States, Florida
Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
U.S. Apple Association
Investigators
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Principal Investigator: 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
More Information
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Responsible Party: Bahram Arjmandi, Margaret A. Sitton Professor, Florida State University
ClinicalTrials.gov Identifier: NCT02224365    
Other Study ID Numbers: RF02435
2015.14930 ( Other Identifier: FSU IRB )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Keywords provided by Bahram Arjmandi, Florida State University:
Diabetes
Arterial Stiffness
Blood Pressure
Endothelial Function
Body Composition
 Glycemic Control
Apples
Functional Foods
Polyphenols
Fiber
Additional relevant MeSH terms:
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Cardiovascular Diseases