Determining the Lipid Lowering Effect of Fenugreek Seed Tea

NCT05858671 | Completed

• 1 other identifier: 20/NI/0057
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hyperlipidemias

Keywords

Fenugreek; Hyperlipidaemia

Outcome Measures

Primary Outcomes (1)

• Serum triglycerides

  The primary outcome of this study is between group differences in mean change in serum triglycerides.

  8 weeks

Secondary Outcomes (6)

• Total-cholesterol

  8 weeks

• LDL-cholesterol

  8 weeks

• non-HDL-cholesterol

  8 weeks

• HDL-cholesterol

  8 weeks

• Plasma apolipoprotein B

  8 weeks

Study Arms (2)

Fenugreek Seed Tea

EXPERIMENTAL

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 designed as being similar to these studies where metabolic effects have been detected and where participant burden will not be too onerous.

Other: Fenugreek Seed Tea

Black Tea

PLACEBO COMPARATOR

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. Therefore, we propose to use black tea as control tea for this study.

Other: Black Tea

Interventions

Fenugreek Seed Tea OTHER

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.

Fenugreek Seed Tea

Black Tea OTHER

A control black tea (2.5g/bag), self-administered by the subjects, twice in a day at a 12-hour interval.

Black Tea

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female patients aged between 18-70 years old
• Patients with hyperlipidaemia (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
• Willing not to change any dietary behaviours, with the exception of participating in the intervention, over the course of the study
• Participants can be recruited onto the study if they are involved in other research studies, but this will depend on the study type and the decision will be made by the Chief Investigator and/or Principal Investigator.

You may not qualify if:

• Patients with type 1 or type 2 diabetes, asthma, allergic reactions, respiratory, kidney, and neurological diseases, psychiatric disorders or pre-existing CVD
• Living in a residential or nursing care home
• Taking high dose nutritional supplements above the dietary reference values
• Consumption of alcohol above current recommended levels (14 units per week), pregnancy or lactation
• Inability to provide informed consent
• Any other problem which would prevent adherence to fenugreek intervention

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (2)

Centre for Public Health, Institute of Clinical Sciences A

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

Queen's University Belfast

Belfast, BT12 6BJ, United Kingdom

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Tea

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jayne Woodside, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study will be single blind as the participants will not know to what treatment they have been allocated until the end of the study. However, as the Postdoctoral Research Fellow will be conducting study visits and allocating participants to their treatment group it will not be possible for them to be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This will be a randomised controlled trial. 114 participants will be randomized into two groups (57/group) to receive either fenugreek seed tea or a control black tea, respectively.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: May 29, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data should be available from June 2024 and will be available for 2 years.
• Access Criteria: Use of results in a meta-analysis.

Locations

GB (2)