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

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ClinicalTrials.gov Identifier: NCT02228837
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : December 8, 2016
Sponsor:
Collaborators:
Pear Bureau Northwest
Washington Tree Fruit Research Commission
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Bahram Arjmandi, Florida State University

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Pear Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome
Study Start Date : August 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
12 weeks of consuming 50 g pear-flavored placebo powder mixed with 480 ml per day (1/2 in the morning and 1/2 in the evening at least 6-8 hours apart).
Dietary Supplement: Placebo
Experimental: Pear
12 weeks of consuming 2 medium-sized pears per day (1 in the morning and 1 in the evening at least 6-8 hours apart).
Dietary Supplement: Pear



Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: 12 weeks ]
    By measuring brachial blood pressure at rest.


Secondary Outcome Measures :
  1. Atherogenic Markers [ Time Frame: 12 weeks ]
    By measuring lipid profiles and atherogenic risk ratios.

  2. Inflammation [ Time Frame: 12 weeks ]
    By measuring markers of inflammation.

  3. Oxidative Stress [ Time Frame: 12 weeks ]
    By measuring markers of oxidative stress.

  4. Insulin Sensitivity [ Time Frame: 12 weeks ]
    By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.

  5. Body Composition [ Time Frame: 12 weeks ]
    By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.

  6. Gastrointestinal Health [ Time Frame: 12 weeks ]
    By using a validated Seven-Day Bowel Movement Questionnaire and serum levels of short-chain fatty acids.



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
  • 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)

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): NCT02228837


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
Pear Bureau Northwest
Washington Tree Fruit Research Commission
USDA Beltsville Human Nutrition Research Center
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: Sarah A. Johnson, PhD, RDN Department of Food Science and Human Nutrition, Colorado State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bahram Arjmandi, Professor, Florida State University
ClinicalTrials.gov Identifier: NCT02228837     History of Changes
Other Study ID Numbers: RF02456
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases