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

August 15, 2013 updated by: Julie Lovegrove, University of Reading

Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
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
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
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

Outcome Measure
Time Frame
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
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
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
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Jordans Cereals (Biggleswade, UK)

Investigators

  • Principal Investigator: Prof. Julie A Lovegrove, BSc, PhD, RNutr, University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 15, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC 09/12
  • University of Reading (Other Identifier: Reading University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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