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

University of Reading

Status: Completed

Conditions: Hypercholesterolemia; Cardiovascular Disease

Treatments: Dietary Supplement: wholegrain cereals oats (WGO); Dietary Supplement: Non wholegrain cereals

Study type: Interventional

Funder types: Other

Identifiers

NCT01925365

University of Reading (Other Identifier)

UREC 09/12

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 23 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Wholegrain cereal oats

Experimental group

Description:

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

Treatment:

Dietary Supplement: wholegrain cereals oats (WGO)

Non wholegrain cereals

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Non wholegrain cereals