Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05858671 |
| Other study ID # |
20/NI/0057 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2023 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Queen's University, Belfast |
| Contact |
Jayne Woodside, PhD |
| Phone |
02890 978942 |
| Email |
j.woodside[@]qub.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this randomized clinical trial is 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. Alteration of plasma microRNAs (e.g. microRNA-122 and
microRNA-34a) will further be analysed for establishing as non-invasive therapeutic
biomarkers of hyperlipidaemia. Participants will be asked to attend three study at baseline,
4 and 8 weeks in the Centre for Public Health. Each visit will involve the collection of
demographic information, anthropometric measurements, blood pressure and fasting blood
samples. Participants allocated to intervention or control will be asked to self-administer
tea twice a day at a 12 hour interval over the 8-week study period. Researchers will compare
the results of the consumption of fenugreek seed tea to the control black tea to see if
fenugreek has any effect on lipid levels.
Description:
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.
Participants without pre-existing CVD or diabetes aged 18-70 years old will be included if
they have hyperlipidemia (plasma triglyceride level between 1.7 - 4.5mmol/l) not on any
lipid-lowering treatment or on a stable lipid-lowering treatment (last six months) but still
have confirmation of high triglycerides within the range required for study.
114 participants will be randomized into two groups (57/group) to receive either fenugreek
seeds or control tea, respectively. Treatment allocations will be placed into sealed
envelopes and this will be opened at the baseline study visit with the participant.
Fenugreek seeds will be delivered at a dose of 5g/day, drunk as a tea (2.5g/per tea bag),
p.o. twice a day at a 12-hour interval) for 8 weeks (56 days). The tea bags will be brewed in
a cup (200ml) of boiled hot water for 10 minutes before drinking. This will be
self-administered by the subjects, twice a day at a 12-hour interval. The rationale for
choosing the dose and intervention time course were based on the previous studies where
metabolic effects have been detected. Literature reports from 12 human studies on diabetic
and pre-diabetic subjects gave doses of fenugreek seed ranging from 1 to 100g/day, with the
median treatment dose being 6.3g/day, to the participants; the intervention time course
ranged from 1 week to 3 years, with the median treatment time being 60 days. The dose and
duration in this study was therefore designed as being similar to these studies where
metabolic effects have been detected, and also, where participant burden will not be too
onerous, at a dose of 5g/day, twice a day at a 12-hour interval for 8 weeks (56 days). For
the control group, a control black tea (2.5g/bag), self-administered by the subjects, twice
in a day at a 12-hour interval. Black tea is a type of fermented tea that has been found to
possess much less cardioprotective and lipid profile improving effect compared to green tea
due to the different manufacture process. Consumption of black tea has been found not
associated with a reduced risk of coronary heart disease in the United Kingdom.
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.
