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

NCT01925365 | Completed DMC

• 2 other identifiers: UREC 09/12University of Reading
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cardiovascular Disease; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (3)

• 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

• 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

• 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.

Study Arms (2)

Wholegrain cereal oats

EXPERIMENTAL

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)

Non wholegrain cereals

PLACEBO COMPARATOR

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

Interventions

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

Wholegrain cereal oats

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.

Non wholegrain cereals

Eligibility Criteria

• Age: 23 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Jordans Cereals (Biggleswade, UK): collaborator

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 20624475 RESULT

• 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.

  PMID: 22360862 RESULT

• Connolly ML, Tzounis X, Tuohy KM, Lovegrove JA. Hypocholesterolemic and Prebiotic Effects of a Whole-Grain Oat-Based Granola Breakfast Cereal in a Cardio-Metabolic "At Risk" Population. Front Microbiol. 2016 Nov 7;7:1675. doi: 10.3389/fmicb.2016.01675. eCollection 2016.

  PMID: 27872611 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Prof. Julie A Lovegrove, BSc, PhD, RNutr

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

GB (1)