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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02035592 on ClinicalTrials.gov