Determining the lipid lowering effect of fenugreek seed tea
Research type
Research Study
Full title
Determining the lipid lowering effect of fenugreek seed tea: a randomized controlled trial
IRAS ID
281398
Contact name
Jayne V Woodside
Contact email
Sponsor organisation
Research & Enterprise Directorate, Queen's University Belfast
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Poor regulation of lipid metabolism and hyperlipidemia are central to the development of cardiovascular disease (CVD). Hyperlipidemia is characterized as the overproduction of very low density cholesterol and low density lipoprotein (LDL) (i.e. bad cholesterol) and decreased high density lipoprotein (HDL) (i.e. good cholesterol). Amongst individuals with mild to moderate hyperlipidemia, lifestyle changes is the first treatment option, such as a healthy diet. Therefore, seeking to develop food-based approaches for hyperlipidemia therapy is a timely endeavour. Fenugreek has been suggested as an attractive option, as it is a spice throughout the world which possesses medicinal properties in regulating human nutrient metabolism. In a recent review of the overall effects of fenugreek on hyperlipidemia in humans with diabetes and prediabetes, this analysis suggested that fenugreek has total cholesterol-lowering efficacy. The effects of fenugreek on triglyceride and LDL-cholesterol showed a trend towards reduction and an incremental trend for HDL-cholesterol but needed further confirmation. The effect of fenugreek in human subjects with hyperlipidemia without diabetes has not been investigated. This research aims to investigate the lipid-lowering effect of fenugreek seed consumed as a tea in patients with hyperlipidaemia, but without diabetes over an 8-week intervention period. Changes in plasma microRNAs will be analysed to establish non-invasive therapeutic biomarkers of hyperlipidemia. 132 patients will be randomized into two equal groups to receive either fenugreek seeds or control tea. Participants, male and female, aged 18-70 years old will be included if they have hyperlipidemia without pre-existing CVD or diabetes and currently not on other lipid-lowering treatment or stable lipid-lowering treatment. Recruitment will be via outpatient hyperlipidemia clinics, primary care and advertisements. Study visits will take place at the Centre for Public Health at baseline, 4 and 8 weeks and will involve the collection of demographic information, anthropometric measurements, blood pressure and fasting blood samples.
REC name
HSC REC A
REC reference
20/NI/0057
Date of REC Opinion
4 May 2020
REC opinion
Favourable Opinion