The Effects of Apple Consumption on Cardiovascular Health in Prediabetics andType 2 Diabetics
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 45 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | August 2014 |
| Contact: | Sarah A. Johnson, PhD, RD, CSO |
| Email: | sba07@my.fsu.edu |
| Phone: | 850-644-4889 |
Regular Apple Consumption Improves Cardiovascular Risk Factors and Glycemic Control in Overweight and Obese Prediabetics and Type 2 Diabetics
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.
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.
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)
We found this trial at
1
site
Tallahassee, Florida 32306
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