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Determining the Lipid Lowering Effect of Fenugreek Seed Tea

Primary Purpose

Hyperlipidemias

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Fenugreek Seed Tea
Black Tea
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyperlipidemias focused on measuring Fenugreek, Hyperlipidaemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Centre for Public Health, Institute of Clinical Sciences ARecruiting
  • Queen's University BelfastRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fenugreek Seed Tea

Black Tea

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total-cholesterol
Between group differences in mean change in total-cholesterol
LDL-cholesterol
Between group differences in mean change in LDL-cholesterol
non-HDL-cholesterol
Between group differences in mean change in non-HDL-cholesterol
HDL-cholesterol
Between group differences in mean change in HDL-cholesterol
Plasma apolipoprotein B
Between group differences in mean change in plasma apolipoprotein B, whose level reflects plasma very low-density lipoprotein (VLDL) contents
MicroRNAs
Between group differences in mean changes of plasma microRNA-122 and microRNA-34a as non-invasive therapeutic biomarkers in human subjects involved in this study

Full Information

First Posted
May 5, 2023
Last Updated
May 5, 2023
Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05858671
Brief Title
Determining the Lipid Lowering Effect of Fenugreek Seed Tea
Official Title
Determining the Lipid Lowering Effect of Fenugreek Seed Tea: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Fenugreek, Hyperlipidaemia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fenugreek Seed Tea
Arm Type
Experimental
Arm Description
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.
Arm Title
Black Tea
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fenugreek Seed Tea
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Black Tea
Intervention Description
A control black tea (2.5g/bag), self-administered by the subjects, twice in a day at a 12-hour interval.
Primary Outcome Measure Information:
Title
Serum triglycerides
Description
The primary outcome of this study is between group differences in mean change in serum triglycerides.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Total-cholesterol
Description
Between group differences in mean change in total-cholesterol
Time Frame
8 weeks
Title
LDL-cholesterol
Description
Between group differences in mean change in LDL-cholesterol
Time Frame
8 weeks
Title
non-HDL-cholesterol
Description
Between group differences in mean change in non-HDL-cholesterol
Time Frame
8 weeks
Title
HDL-cholesterol
Description
Between group differences in mean change in HDL-cholesterol
Time Frame
8 weeks
Title
Plasma apolipoprotein B
Description
Between group differences in mean change in plasma apolipoprotein B, whose level reflects plasma very low-density lipoprotein (VLDL) contents
Time Frame
8 weeks
Title
MicroRNAs
Description
Between group differences in mean changes of plasma microRNA-122 and microRNA-34a as non-invasive therapeutic biomarkers in human subjects involved in this study
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayne Woodside, PhD
Phone
02890 978942
Email
j.woodside@qub.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Logan, PhD
Email
d.logan@qub.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayne Woodside, PhD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Public Health, Institute of Clinical Sciences A
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayne Woodside, Prof
Phone
02890 978942
Email
j.woodside@qub.ac.uk
First Name & Middle Initial & Last Name & Degree
Danielle Logan, PhD
Email
d.logan@qub.ac.uk
Facility Name
Queen's University Belfast
City
Belfast
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayne V Woodside, PhD
Phone
02890 978942
Email
j.woodside@qub.ac.uk
First Name & Middle Initial & Last Name & Degree
Danielle Logan, PhD
Email
d.logan@qub.ac.uk
First Name & Middle Initial & Last Name & Degree
Jayne V Woodside, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The researchers are happy to share results from the study for the purposes of a meta-analysis. This will be completed on approach to the researchers.
IPD Sharing Time Frame
Data should be available from June 2024 and will be available for 2 years.
IPD Sharing Access Criteria
Use of results in a meta-analysis.

Learn more about this trial

Determining the Lipid Lowering Effect of Fenugreek Seed Tea

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