The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02228837|
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: Pear Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- Blood Pressure [ Time Frame: 12 weeks ]By measuring brachial blood pressure at rest.
- Atherogenic Markers [ Time Frame: 12 weeks ]By measuring lipid profiles and atherogenic risk ratios.
- Inflammation [ Time Frame: 12 weeks ]By measuring markers of inflammation.
- Oxidative Stress [ Time Frame: 12 weeks ]By measuring markers of oxidative stress.
- Insulin Sensitivity [ Time Frame: 12 weeks ]By measuring fasting glucose, insulin, homeostatic model of insulin resistance, and hemoglobin A1C.
- Body Composition [ Time Frame: 12 weeks ]By measuring fat mass and fat-free mass using dual-energy X-ray absorptiometry and anthropometrics.
- Gastrointestinal Health [ Time Frame: 12 weeks ]By using a validated Seven-Day Bowel Movement Questionnaire and serum levels of short-chain fatty acids.
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
|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|
|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|