Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease
NCT ID: NCT01925365
Last Updated: 2013-08-19
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
30 participants
INTERVENTIONAL
2009-05-31
2010-05-31
Brief Summary
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The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Wholegrain cereal oats
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period.
wholegrain cereals oats (WGO)
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period
Non wholegrain cereals
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Non wholegrain cereals
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Interventions
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wholegrain cereals oats (WGO)
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period
Non wholegrain cereals
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Eligibility Criteria
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Inclusion Criteria
* BMI of 18-30kg/m2
* Fasting glucose concentration \>5.5 but \<7.5mmol/L
* Total cholesterol \>5.2 but \<7.8mmol/L
Exclusion Criteria
* use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis
* exposure to any investigational agent \<42 d before the study
* presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption
* history of substance misuse or alcoholism
* current pregnancy, planned pregnancy, or given birth in the past 12 months
* antibiotic treatment 6 weeks previous to study start date
* allergy or intolerance to intervention breakfast cereals components
* smoking
23 Years
64 Years
ALL
Yes
Sponsors
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Jordans Cereals (Biggleswade, UK)
UNKNOWN
University of Reading
OTHER
Responsible Party
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Julie Lovegrove
Professor
Principal Investigators
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Prof. Julie A Lovegrove, BSc, PhD, RNutr
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom
Countries
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References
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Connolly ML, Lovegrove JA, Tuohy KM. In vitro evaluation of the microbiota modulation abilities of different sized whole oat grain flakes. Anaerobe. 2010 Oct;16(5):483-8. doi: 10.1016/j.anaerobe.2010.07.001. Epub 2010 Jul 17.
Connolly ML, Tuohy KM, Lovegrove JA. Wholegrain oat-based cereals have prebiotic potential and low glycaemic index. Br J Nutr. 2012 Dec 28;108(12):2198-206. doi: 10.1017/S0007114512000281. Epub 2012 Feb 24.
Connolly ML, Tzounis X, Tuohy KM, Lovegrove JA. Hypocholesterolemic and Prebiotic Effects of a Whole-Grain Oat-Based Granola Breakfast Cereal in a Cardio-Metabolic "At Risk" Population. Front Microbiol. 2016 Nov 7;7:1675. doi: 10.3389/fmicb.2016.01675. eCollection 2016.
Other Identifiers
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University of Reading
Identifier Type: OTHER
Identifier Source: secondary_id
UREC 09/12
Identifier Type: -
Identifier Source: org_study_id