The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228837
• Other study ID #: RF02456
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2014
• Last updated: December 6, 2016
• Start date: August 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Pear

• Placebo

Locations

Country	Name	City	State
United States	Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University	Tallahassee	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Florida State University	Pear Bureau Northwest, USDA Beltsville Human Nutrition Research Center, Washington Tree Fruit Research Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	By measuring brachial blood pressure at rest.	12 weeks	No
Secondary	Atherogenic Markers	By measuring lipid profiles and atherogenic risk ratios.	12 weeks	No
Secondary	Inflammation	By measuring markers of inflammation.	12 weeks	No
Secondary	Oxidative Stress	By measuring markers of oxidative stress.	12 weeks	No
Secondary	Insulin Sensitivity	By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.	12 weeks	No
Secondary	Body Composition	By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.	12 weeks	No
Secondary	Gastrointestinal Health	By using a validated Seven-Day Bowel Movement Questionnaire and serum levels of short-chain fatty acids.	12 weeks	No

External Links

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