Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease
Primary Purpose
Cardiovascular Disease, Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
wholegrain cereals oats (WGO)
Non wholegrain cereals
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Disease
Eligibility Criteria
Inclusion Criteria:
- Men and Women (age range 23-64 y)
- BMI of 18-30kg/m2
- Fasting glucose concentration >5.5 but <7.5mmol/L
- Total cholesterol >5.2 but <7.8mmol/L
Exclusion Criteria:
- medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease
- 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
Sites / Locations
- Department of Food and Nutritional Sciences, University of Reading
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Wholegrain cereal oats
Non wholegrain cereals
Arm Description
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period.
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Outcomes
Primary Outcome Measures
Changes in faecal bacteria population
Secondary Outcome Measures
Faecal short chain fatty acids
Changes in plasma lipids
Full Information
NCT ID
NCT01925365
First Posted
August 15, 2013
Last Updated
August 15, 2013
Sponsor
University of Reading
Collaborators
Jordans Cereals (Biggleswade, UK)
1. Study Identification
Unique Protocol Identification Number
NCT01925365
Brief Title
Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease
Official Title
Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
Jordans Cereals (Biggleswade, UK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Hypercholesterolemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wholegrain cereal oats
Arm Type
Experimental
Arm Description
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period.
Arm Title
Non wholegrain cereals
Arm Type
Placebo Comparator
Arm Description
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Intervention Type
Dietary Supplement
Intervention Name(s)
wholegrain cereals oats (WGO)
Intervention Description
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period
Intervention Type
Dietary Supplement
Intervention Name(s)
Non wholegrain cereals
Intervention Description
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Primary Outcome Measure Information:
Title
Changes in faecal bacteria population
Time Frame
Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days
Secondary Outcome Measure Information:
Title
Faecal short chain fatty acids
Time Frame
High-performance liquid chromatography (HPLC) was performed to determine faecal SCFA concentration. Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days
Title
Changes in plasma lipids
Time Frame
Fasted plasma samples were analysed for determination of triacylglycerol (TAG), total cholesterol (TC), HDL-cholesterol, LDL-cholesterol. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days
Other Pre-specified Outcome Measures:
Title
Changes in insulin resistance, PYY and GLP-1
Time Frame
Fasted plasma samples were analysed for determination of insulin resistance, PYY and GLP-1. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days
Title
Changes in inflammatory markers
Time Frame
Fasted plasma samples were analysed for determination of IL-6, TNF-a while saliva samples were analysed for sIgA and faecal samples for calprotectin. Blood plasma samples and saliva and faecal samples were collected and analysed at 0, 42, 56, 112, 140
Title
Changes in dietary intake
Time Frame
4-day diet diaries were collected analysed, to determine the macro and micronutrient content of the participant's diets during each intervention arm. Diet diaries were collected at were collected and analysed at 42 and 112 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and Women (age range 23-64 y)
BMI of 18-30kg/m2
Fasting glucose concentration >5.5 but <7.5mmol/L
Total cholesterol >5.2 but <7.8mmol/L
Exclusion Criteria:
medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Julie A Lovegrove, BSc, PhD, RNutr
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20624475
Citation
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.
Results Reference
result
PubMed Identifier
22360862
Citation
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.
Results Reference
result
PubMed Identifier
27872611
Citation
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.
Results Reference
derived
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Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease
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