The Health Effects of Blueberry Anthocyanins in Metabolic Syndrome (the CIRCLES-study)
NCT02035592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2017-09-29
Summary
The purpose of this study is to determine the dose-dependent impact of 6 month freeze-dried blueberry powder intake on insulin sensitivity and resistance, cardiovascular disease risk factors, and lung and cognitive function in overweight and obese participants with metabolic syndrome. We will also examine acute post-prandial effects of blueberry intake (at baseline and at 6-months).
Conditions
- Insulin Resistance
- Metabolic Syndrome X
Interventions
- OTHER
-
Full dose blueberry
Full dose: 26g of freeze dried blueberry powder to be incorporated into the habitual diet. Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.
- OTHER
-
Half dose blueberry
Half dose: 26g of freeze dried powder (containing 13g of freeze dried blueberry powder and 13g of placebo comparator material) to be incorporated into the habitual diet. Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.
- OTHER
-
Control
Control: 26g of placebo comparator material to be incorporated into the habitual diet. Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.
Sponsors & Collaborators
-
Harvard School of Public Health (HSPH)
collaborator OTHER -
University of East Anglia
lead OTHER
Principal Investigators
-
Aedin Cassidy, PhD · University of East Anglia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2016-11-07
- Completion
- 2016-11-07
Countries
- United States
- United Kingdom
Study Locations
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