The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 45 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | August 2016 |
| Contact: | Sarah A. Johnson, PhD, RD, CSO |
| Email: | sba07@my.fsu.edu |
| Phone: | 850-644-4889 |
The hypothesis of this study is that the daily consumption of 2 medium-sized pears for
twelve weeks will improve blood pressure, lipid profiles, glycemic control and insulin
resistance, inflammatory and oxidative status in men and women with metabolic syndrome. 50
men and women between the ages of 45 and 65 who have three of the five features of metabolic
syndrome as defined by the Adult Treatment Panel III 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) 2 medium-sized pears; or 2) 50 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 waist circumference, resting brachial blood
pressure, fasting serum triglycerides, high density lipoprotein cholesterol, and glucose
levels to confirm metabolic syndrome. 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 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.
Anthropometrics and body composition will be measured. Questionnaires regarding diet,
physical activity, and gastrointestinal health will be performed. Participants will be
provided with their assigned treatment and will receive standard instructions on how to fill
out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),
and 12-week (final visit) intervals. All assessments and information will be collected 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. After the initial 12 weeks, participants
will undergo a 4-week washout period in which they will not consume either the intervention
or the placebo. After the 4-week washout period, participants will crossover into the other
group to receive either the intervention or placebo.
twelve weeks will improve blood pressure, lipid profiles, glycemic control and insulin
resistance, inflammatory and oxidative status in men and women with metabolic syndrome. 50
men and women between the ages of 45 and 65 who have three of the five features of metabolic
syndrome as defined by the Adult Treatment Panel III 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) 2 medium-sized pears; or 2) 50 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 waist circumference, resting brachial blood
pressure, fasting serum triglycerides, high density lipoprotein cholesterol, and glucose
levels to confirm metabolic syndrome. 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 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.
Anthropometrics and body composition will be measured. Questionnaires regarding diet,
physical activity, and gastrointestinal health will be performed. Participants will be
provided with their assigned treatment and will receive standard instructions on how to fill
out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),
and 12-week (final visit) intervals. All assessments and information will be collected 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. After the initial 12 weeks, participants
will undergo a 4-week washout period in which they will not consume either the intervention
or the placebo. After the 4-week washout period, participants will crossover into the other
group to receive either the intervention or placebo.
Inclusion Criteria:
- Men and women
- Aged 45-65 years old
- Three of the following five features at the screening visit:
- Waist circumference of ≥ 40 inches for men and 35 inches for women
- Serum triglycerides ≥ 150 mg/dL
- Serum high density lipoprotein cholesterol levels < 40 mg/dL for men and <50 mg/dL
for women
- Blood pressure ≥ 130/85 mm Hg
- Fasting blood glucose level ≥ 110 mg/dL
Exclusion Criteria:
- Taking hypoglycemic, antihypertensive or cholesterol-lowering medications
- Diagnosed cardiovascular disease
- Uncontrolled hypertension (≥ 160/100 mmHg)
- Diabetes mellitus
- 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)
We found this trial at
1
site
Tallahassee, Florida 32306
Principal Investigator: Bahram H. Arjmandi, PhD, RD
Phone: 850-644-4889
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