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

N/ACompletedNCT01925365

University of Reading30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Cardiovascular Disease Hypercholesterolemia

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 cerealsDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 23 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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