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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925365
• Other study ID #: UREC 09/12
• Secondary ID: University of Re
• Status: Completed
• Phase: N/A
• First received: August 15, 2013
• Last updated: August 15, 2013
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2013
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: University of Reading - University Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Jordans Cereals (Biggleswade, UK)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Connolly ML, Lovegrove JA, Tuohy KM. In vitro evaluation of the microbiota modulation abilities of different sized whole oat grain flakes. Anaerobe. 2010 Oct;16(5):483-8. doi: 10.1016/j.anaerobe.2010.07.001. Epub 2010 Jul 17. — View Citation

Connolly ML, Tuohy KM, Lovegrove JA. Wholegrain oat-based cereals have prebiotic potential and low glycaemic index. Br J Nutr. 2012 Dec 28;108(12):2198-206. doi: 10.1017/S0007114512000281. Epub 2012 Feb 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in insulin resistance, PYY and GLP-1		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	No
Other	Changes in inflammatory markers		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	No
Other	Changes in dietary intake		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.	No
Primary	Changes in faecal bacteria population		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	No
Secondary	Faecal short chain fatty acids		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	No
Secondary	Changes in plasma lipids		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	No