The effects of 8 weeks of a Fenugreek extract supplementation in combination with exercise training on exercise capacity in healthy young males
RDC Global Pty Ltd
150 participants
Aug 12, 2018
Interventional
Conditions
Summary
Approximately 150 male participants aged between 18-40 years of age will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications, physical assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=50) or one of two active intervention groups (n=50 per group). Height, weight, body composition, cardiovascular function, and treadmill exercise testing and questionnaires regarding gastrointestinal tolerance, score of fatigue, and quality of life will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. Participants will be asked to take the allocated product according to the dose prescribed. In addition, participants will be asked to undertake the training program consisting of aerobic training. Participants will complete 4 training sessions per week and undertake further assessment at weeks 4 and 8. At the mid-point (week 4) participants will complete treadmill exercise testing, as well as having weight and waist circumference assessment. At the completion of the study (week 8), an assessment identical to what was undertaken at baseline will be carried out. At both time points (week 4 and 8) and as part of the assessment, participants will be interviewed and asked to provide details regarding any lifestyle changes (diet, exercise, medication) in addition to subjective changes in exercise, performance and any adverse effects (including change in libido and mood).
Eligibility
Inclusion Criteria6
- 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 Criteria13
- 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
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Interventions
The investigational product (Fenugreek) is an ARTG listed commercially available capsule-form herbal medicine containing a purified extract of Fenugreek seed extract. Arm 1: Active treatment with 300mg/day split between 2 doses, one capsule taken in the morning and one capsule in the evening for 8 weeks. Arm 2: Active treatment with 600mg/day split between 2 doses, one capsule taken in the morning and one capsule in the evening for 8 weeks. Arm 3: Placebo taken for 8 weeks. Adherence will be monitored by trial product container return and capsule count at the end of the study. Participants will undertake a set exercise routine of running on a treadmill for between 35-50min 4 x weekly during weeks 1-3 and 5-7. Specifically the following regime will be prescribed: Week 1: 35min duration running at 60-70% HRmax Week 2: 35min duration running at 65-75% HRmax Week 3: 40min duration running at 65-75% HRmax Week 4: 40min duration running at 70-80% HRmax Week 5: 45min duration running at 70-80% HRmax Week 6: 45min duration running at 75-85% HRmax Week 7: 50min duration running at 75-85% HRmax Week 8: 50min duration running at 80-85% HRmax During weeks 4 and 8, participants will be asked to undertake 3 x weekly exercise sessions instead of 4 and attend the study site for an exercise assessment which involves running on a treadmill. An exercise physiologist will be undertaking the exercise assessment and remaining sessions can be done at home or in the gym depending on personal preference and access to a treadmill. Participants will be asked to monitor their own activity through Strava (phone app) which the exercise physiologist can also see.
Locations(1)
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ACTRN12618001356257