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Completed

NCT Number: NCT01925365

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

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

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

23 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wholegrain cereals oats (WGO)

Dietary Supplement

Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period

Non wholegrain cereals

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Jordans Cereals (Biggleswade, UK)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Aug 19, 2013
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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