NCT02035592

The Health Effects of Blueberry Anthocyanins in Metabolic Syndrome (the CIRCLES-study)

The Effects of Blueberry Anthocyanins on Insulin Resistance and Vascular, Lung and Cognitive Function in a Population With Metabolic Syndrome.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-11-07
• Completion: 2016-11-07
• First posted: 2014-01-14
• Last updated: 2017-09-29

Locations

4 sites across 2 countries: United States, United Kingdom