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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: 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. CONDITION: Exercise capacity PRIMARY OUTCOME: Time to reach exhaustion measured by wingate test Time to reach exhaustion stage measured via graded treadmill test SECONDARY OUTCOME: ; Muscle fatigue ‐ change in Wingate anaerobic power ; Change in ventilatory threshold during VO2max test ; ; Change in VO2 max during VO2max test Change in blood pressure using a blood pressure monitor Change in heart rate using a heart rate monitor Change in mental focus measured by blood and saliva cortisol test Change in respiratory exchange ratios during VO2max test Change in total running distance measured using a treadmill Change in total running time using a treadmill Energy expenditure measured by Multidimensional ; Fatigue Syndrome Inventory‐ Short Form( MFSI‐SF) questionnaire Energy expenditure measured by change in blood free fatty acids Energy expenditure measured by change in fasting glucose blood test Energy expenditure measured by change in metabolic equivalents measured via gas analysis during the VO2max test body weight using a scale change in mental focus measured by Multidimensional 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 ; Fatigue Syndrome Inventory‐ Short Form( MFSI‐SF) questionnaire change in muscle fatigue score measured by VAS questionnaire height measured using a stadiometer hip circumference measured using a tape measure Muscle fatigue ‐ change in fatigue score by validated fatigue scale questionnaire MSFI Quality of life measured by physical activity readiness questionnaire Quality of life measured by short form‐36 questionnaire Safety ‐ blood test measuring kidney function ‐ creatine Safety ‐ blood test measuring kidney function ‐ eGFR safety ‐ blood test measuring sodium Safety measured by the 'Gastrointestinal Tolerance Questionnaire' Safety via a blood test measuring albumin Safety via a blood test measuring Liver enzyme ALT Safety via a blood test measuring Liver enzyme AST Safety via a blood test measuring Liver enzyme GGT safety‐ blood test measuring potassium Waist circumference measured using a tape measure Waist hip ratio measured using a tape measure
Epistemonikos ID: d7e51a21fb437e89d5ee8c19582e9f411919fa22
First added on: Aug 25, 2024