The effects of 8 weeks of a Fenugreek extract supplementation in combination with exercise training on exercise capacity in healthy young males

Phase 4

Completed

• Conditions: Exercise capacity; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12618001356257
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-10
• Study Completion: 2020-06-01
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 153

Inclusion Criteria

Males over 18-40 years
Normal dietary habits (no medically prescribed diet, no slimming diet, no vegan or macrobiotic diet)
Otherwise healthy, BMI 18.5-25 kg/m2
Able to provide informed consent
Agree not to change current diet and exercise program, or not to use other dietary supplements other than the test product during entire study period.
Exercising a minimum of 2 days per week

Exclusion Criteria

Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)
Malignancy or treatment for malignancy within the previous 2 years
Receiving/ prescribed coumadin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
People with serious mood disorders (such as depression and bipolar disorder) will be excluded. The Hamilton Rating Scale for Depression could be used as a screening form to ensure that those with undiagnosed depression are not enrolled into the study
Those suffering from insomnia or have night-shift employment and unable to have a normal night’s sleep
People suffering any neurological disorders such as MS
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Participants who have participated in any other clinical trial during the past 3 months
Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
History of infection in the month prior to the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified