Effect of bioactive enriched food on markers of metabolic syndrome
Research type
Research Study
Full title
Pivotal assessment of the effects of bioactives on health and wellbeing. From human genoma to food industry - PATHWAY-27.
IRAS ID
193001
Contact name
Caroline Orfila
Contact email
Sponsor organisation
Unviersity of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
Are ready-made foods enriched with bioactive ingredients effective at improving markers of the metabolic syndrome (MetS)?\n\nIt is estimated that 1 in 4 adults in the UK are affected by MetS. MetS is a medical term used to describe the combination of obesity, high blood pressure, elevated fasting blood glucose and triglycerides, and low levels of HDL cholesterol. Together these conditions increase the risk of developing heart disease and diabetes.\n\nThere is scientific evidence to support health claims that omega-3 fatty acids and oat beta-glucan can help to maintain healthy cholesterol, however research often focuses on individual bioactive compounds administered as supplements. This intervention study aims to investigate the effect of bioactive compounds in combination when used as ingredients in common foods. Healthy adult volunteers, at risk of or with MetS, will be asked to eat bioactive enriched food and/or placebo daily for 12 weeks. Participants must have raised fasting blood triglycerides plus at least one, and no more than 3, of the other conditions associated with the metabolic syndrome (low HDL cholesterol, elevated fasting glucose, high blood pressure, abdominal obesity).\n\nThis multi-centre study, funded by the European Commission, will recruit 200 participants in each the UK, France, Germany and Italy. In the UK all recruitment will be conducted by the University of Leeds. All participants will provide blood and urine samples, have blood pressure, height, weight and waist circumference measured, and complete dietary assessment records. A subgroup of participants (40 per centre) will be asked to provide faecal samples, have abdominal fat tissue removed, undergo body composition scans and complete physical activity assessments. Participation in subgroup activities is optional. Samples will be analysed in the UK, Germany and Italy.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0091
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion