Clinical trial NCT02224365: The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics
Official title: Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Cardiovascular Diseases
Prediabetes
Keywords: Diabetes
Arterial Stiffness
Blood Pressure
Endothelial Function
Body Composition
Glycemic Control
Apples
Functional Foods
Polyphenols
Fiber
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: U.S. Apple Association
First posted: 2014-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Arterial Stiffness
timeFrame: 12 weeks
measure: Autonomic Control of Blood Pressure
timeFrame: 12 weeks
measure: Endothelial-mediated Vasodilation
timeFrame: 12 weeks
measure: Inflammation
timeFrame: 12 weeks
measure: Oxidative Stress
timeFrame: 12 weeks
measure: Insulin Sensitivity
timeFrame: 12 weeks
measure: Atherogenic Markers
timeFrame: 12 weeks
measure: Body Composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
state: Florida
Study officials:
affiliation: Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University
name: Bahram H. Arjmandi, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Food and Exercise Sciences, Florida State University
name: Arturo Figueroa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Food Science and Human Nutrition, Colorado State University
name: Sarah A. Johnson, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References: