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Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01925365
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : August 19, 2013
Sponsor:
Collaborator:
Jordans Cereals (Biggleswade, UK)
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

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


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Hypercholesterolemia Dietary Supplement: wholegrain cereals oats (WGO) Dietary Supplement: Non wholegrain cereals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population
Study Start Date : May 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wholegrain cereal oats
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period.
Dietary Supplement: 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

Placebo Comparator: Non wholegrain cereals
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
Dietary Supplement: Non wholegrain cereals
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. 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. ]


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Ages Eligible for Study:   23 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925365


Locations
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United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Jordans Cereals (Biggleswade, UK)
Investigators
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Principal Investigator: Prof. Julie A Lovegrove, BSc, PhD, RNutr University of Reading

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01925365    
Other Study ID Numbers: UREC 09/12
University of Reading ( Other Identifier: Reading University )
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Hypercholesterolemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases