The Health Effects of Blueberry Anthocyanins in Metabolic Syndrome (the CIRCLES-study)
NCT ID: NCT02035592
Last Updated: 2017-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2014-01-31
2016-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Full dose blueberry
26g of freeze dried blueberry powder; equivalent to 2 portions of fresh blueberries per day.
Frequency: 26g per day.
Total duration: 6-month.
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.
Half dose blueberry
26g of freeze dried powder; containing 13g of freeze dried blueberry powder and 13g of placebo comparator material; equivalent to 1 portion of fresh blueberries per day.
Frequency: 26g per day.
Total duration: 6-month.
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.
Control
Matched control powder; matched for appearance, taste and sugar content.
Frequency: 26g per day.
Total duration: 6-month.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 50 to 75 years old
* BMI of ≥ 25 kg/m2
* 3 characteristics of metabolic syndrome i.e: Waist circumference ≥ 102 cm for men, ≥ 88 cm for women; Triglycerides ≥ 1.7 mmol/L (or drug treatment for elevated triglycerides); HDL-cholesterol \< 1.0 mmol/L for men, \< 1.3 mmol/L for women (or drug treatment for low HDL-cholesterol); Blood pressure ≥ 130 mm Hg systolic and/or ≥ 85 mm Hg diastolic blood pressure; Fasting blood glucose ≥ 5.56 mmol/L
* Successful biochemical, haematological and urinalysis assessment at screening
Exclusion Criteria
* Existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures
* Fructose intolerance or known allergies to the intervention treatments
* On therapeutic diets or having experienced substantial weight loss within 3 months of screening
* Taking flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial)
* Planning on altering consumption of vitamin supplements / fish oil capsules during the course of the study.
* Prescribed hypoglycaemic, vasodilators or HRT medication.
* Unsatisfactory biochemical, haematological or urinary assessment at screening, or measures considered to be counter indicative for the study
* \< 3 characteristics of the metabolic syndrome.
NB: REC approved NoSA granted to include those on anti-hypertensives (29JUL2014)
50 Years
74 Years
ALL
No
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
University of East Anglia
OTHER
Responsible Party
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Principal Investigators
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Aedin Cassidy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of East Anglia
Locations
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Harvard School of Public Health
Boston, Massachusetts, United States
Addenbrooke's hospital
Cambridge, Cambridgeshire, United Kingdom
Norwich Medical School University of East Anglia
Norwich, Norfolk, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Countries
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References
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Curtis PJ, van der Velpen V, Berends L, Jennings A, Haag L, Minihane AM, Chandra P, Kay CD, Rimm EB, Cassidy A. Chronic and postprandial effect of blueberries on cognitive function, alertness, and mood in participants with metabolic syndrome - results from a six-month, double-blind, randomized controlled trial. Am J Clin Nutr. 2024 Mar;119(3):658-668. doi: 10.1016/j.ajcnut.2023.12.006. Epub 2024 Feb 6.
Curtis PJ, Berends L, van der Velpen V, Jennings A, Haag L, Chandra P, Kay CD, Rimm EB, Cassidy A. Blueberry anthocyanin intake attenuates the postprandial cardiometabolic effect of an energy-dense food challenge: Results from a double blind, randomized controlled trial in metabolic syndrome participants. Clin Nutr. 2022 Jan;41(1):165-176. doi: 10.1016/j.clnu.2021.11.030. Epub 2021 Nov 27.
Curtis PJ, van der Velpen V, Berends L, Jennings A, Feelisch M, Umpleby AM, Evans M, Fernandez BO, Meiss MS, Minnion M, Potter J, Minihane AM, Kay CD, Rimm EB, Cassidy A. Blueberries improve biomarkers of cardiometabolic function in participants with metabolic syndrome-results from a 6-month, double-blind, randomized controlled trial. Am J Clin Nutr. 2019 Jun 1;109(6):1535-1545. doi: 10.1093/ajcn/nqy380.
Other Identifiers
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R21478-C
Identifier Type: -
Identifier Source: org_study_id