Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males

Study Overview
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Brief Summary
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This is a randomized, repeated measures and double blind study which measures the effect of fenugreek extract on markers of muscle damage and inflammation in non-resistance trained males. Participants will complete baseline testing and then be randomized into groups. Participants will complete a 2 week, split-body resistance training program. They will then return for testing in which they will complete an overreaching protocol for 5 consecutive days. Measurements will be recorded 24 hrs after the fifth day. Participants will resume the training program for one additional week and return for final measurements.

Detailed Description
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Subjects expressing interest in doing the study will be interviewed in the UMHB Human Performance Lab (HPL) to determine whether they qualify to participate in the study. Upon qualification, participants will be scheduled a familiarization session in which they will be taught how to perform a proper bench press, back squat, deadlift and squat thruster. They will then schedule their first testing session which will include: a body composition analysis via an InBody 770, thigh circumference measurements, joint mobility measurements, a blood draw, strength testing (1RM), and muscular endurance testing (70% 1RM max reps). Participants will then be placed in groups based on fat free mass and assigned their workout program (3days/week) with training loads based on their 1RM values (bench press, back squat, deadlift and squat thruster). Supplementation protocol: Participants will be randomly assigned into one of three groups and instructed to ingest capsules of either a placebo, or IND03 (fenugreek extract) containing 300mg, or 500mg. They will supplement 1 hour prior to their workout each exercise day as well as during the overreaching week. On off/rest days, participants will consume capsules in the morning with breakfast. After two weeks of training, participants will return to the HPL for follow-up strength testing (1RM), and muscular endurance testing (70% 1RM max reps), then instructed to rest for 48 hours and return to the lab to begin their overreaching protocol. During each of the 5 days, participants undergo the following measurements prior to the exercise protocol: thigh circumference, joint mobility, and questionnaires (WOMAC & VAS). On Day 1 participants will also perform an InBody and blood draw. A blood draw will also be performed on Day 3. They will then consume a standardized snack and begin the overreaching protocol of 8 sets of 10 repetitions for the following 4 exercises: bench press, back squat, deadlift and squat thruster. There will be a 1 minute rest period in between each set and a 2 minute rest in between each exercise. Participants will then fill out a Rate of Perceived Exertion (RPE) immediately after the protocol. Again, they will perform this for 5 consecutive days. Twenty-four hours after the last overreaching day, participants will return for thigh circumference, joint mobility, questionnaires (WOMAC & VAS), a blood draw, strength testing (1RM), and muscular endurance testing (70% 1RM max reps). They will then be instructed to continue the resistance training program for 1 week. After that period they will return for final measurements of thigh circumference, joint mobility, questionnaires (WOMAC & VAS), a blood draw, strength testing (1RM), and muscular endurance testing (70% 1RM max reps). Throughout the duration of the study, participants will record their dietary intake via MyFitnessPal.

Official Title
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Evaluation of the Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation on Healthy Non-resistance Trained Participants

Conditions
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Muscle Damage, Inflammation

Intervention / Treatment
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* Other: Sugar Pill
* Dietary Supplement: Fenugreek Extract, Low Dose
* Dietary Supplement: Fenugreek Extract, High Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be males between the age of 18-45; Subjects will have not been participating in a structured resistance training program in the past 6 months; Subjects will be provided written and dated informed consent to participate in the study; Subjects will be willing and able to comply with the protocol; Subjects will be apparently healthy and free from disease, as determined by a health history questionnaire; Subjects will agree to abstain from exercise 48 hours prior to each testing visit; Subjects will agree to fast for 10 hours prior to each testing visit; Subjects will be agree to refrain from tobacco use, alcohol and/or caffeine consumption and/or smoking 12 hours prior to each testing visit; Subjects will agree to refrain from taking any supplement that may interfere with study supplementation for the remainder of the study. Exclusion Criteria: Subject has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB) or anabolic/catabolic hormone levels (e.g., androstenedione, DHEA, etc.) within 3 months prior to the start of the study; Subject is unable to complete blood draws needed at each testing session; Subject reports any unusual adverse events associated with this study that in consultation with the supervising physician recommends removal from the study; Subject does not complete 90% of resistance training program assigned; Subject is unable to complete overreaching protocol during overreaching week;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups: placebo, 300mg dose (low) and 500mg dose (high)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar Pill<br>Maltodextrin (matches the weight of the active treatment). Taken 1-hour prior to workout on training days and each day of overreaching week. On rest days, will consume in the morning with breakfast. | Other: Sugar Pill<br>* Taken orally in capsule form<br>|
| Experimental: Fenugreek Extract, Low Dose<br>300mg Taken 1-hour prior to workout on training days and each day of overreaching week. On rest days, will consume in the morning with breakfast. | Dietary Supplement: Fenugreek Extract, Low Dose<br>* Taken orally in capsule form<br>|
| Experimental: Fenugreek Extract, High Dose<br>500mg Taken 1-hour prior to workout on training days and each day of overreaching week. On rest days, will consume in the morning with breakfast. | Dietary Supplement: Fenugreek Extract, High Dose<br>* Taken orally in capsule form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Fenugreek Extract on Interleukin-1 | The primary purpose of this investigation is to determine the effectiveness of fenugreek extract on blunting an exercise-induced state of inflammation during a period of high volume and overreaching resistance exercise in young, non-resistance trained males. This will be accomplished by observing blood markers prior to, during and post exercise testing. | within 26 days | 
| Effect of Fenugreek Extract on Creatine Kinase | The primary purpose of this investigation is to determine if supplementation of fenugreek extract will have a protective effect on muscle damage in response to resistance exercise. This will be accomplished by observing blood markers prior to, during and post exercise testing. | within 26 days | 
| Effect of Fenugreek Extract on Interleukin-6 | The primary purpose of this investigation is to determine the effectiveness of fenugreek extract on blunting an exercise-induced state of inflammation during a period of high volume and overreaching resistance exercise in young, non-resistance trained males. This will be accomplished by observing blood markers prior to, during and post exercise testing. | within 26 days | 
| Effect of Fenugreek Extract on Tumor Necrosis Factor Alpha (TNF-α) | The primary purpose of this investigation is to determine the effectiveness of fenugreek extract on blunting an exercise-induced state of inflammation during a period of high volume and overreaching resistance exercise in young, non-resistance trained males. This will be accomplished by observing blood markers prior to, during and post exercise testing. | within 26 days | 
| Effect of Fenugreek Extract on C-reactive protein | The primary purpose of this investigation is to determine the effectiveness of fenugreek extract on blunting an exercise-induced state of inflammation during a period of high volume and overreaching resistance exercise in young, non-resistance trained males. This will be accomplished by observing blood markers prior to, during and post exercise testing. | within 26 days | 
| Effect of Fenugreek Extract on 3-methylhistidine | The primary purpose of this investigation is to determine if supplementation of fenugreek extract will have a protective effect on muscle damage in response to resistance exercise. This will be accomplished by observing blood markers prior to, during and post exercise testing. | within 26 days | 
| Effect of Fenugreek Extract on Lactate Dehydrogenase | The primary purpose of this investigation is to determine if supplementation of fenugreek extract will have a protective effect on muscle damage in response to resistance exercise. This will be accomplished by observing blood markers prior to, during and post exercise testing. | within 26 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Fenugreek Extract on Glucose mg/dL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Urea Nitrogen (BUN) mg/Dl | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Creatinine mg/Dl | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on eGFR Non-Afr. American mL/min/1.73m2 | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on eGFR African American mL/min/1.73m2 | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on BUN/Creatinine Ratio calculated | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Sodium mmol/L | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Potassium mmol/L | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Chloride mmol/L | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Carbon Dioxide mmol/L | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Calcium mg/Dl | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Protein, Total g/Dl | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Albumin g/dL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Globulin g/Dl | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Albumin/Globulin Ratio calculated | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Bilirubin, Total mg/Dl | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Alkaline Phosphatase U/L | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Aspartate Aminotransferase U/L | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Alanine Aminotransferase U/L | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a comprehensive metabolic panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on White Blood Cell Count thousand/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Red Blood Cell Count million/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Hemoglobin g/dL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Hematocrit % | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on MCV fL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on MCH pg | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on MCHC g/dL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on RDW % | v | within 26 days | 
| Effect of Fenugreek Extract on Platelet Count thousand/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on MPV fL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Absolute Neutrophils cells/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Absolute Lymphocytes cells/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Absolute Monocytes cells/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Absolute Eosinophils cells/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Absolute Basophils cells/uL | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Neutrophils % | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Lymphocytes % | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Monocytes % | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Eosinophils % | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 
| Effect of Fenugreek Extract on Basophils % | The secondary purpose is to assess safety of ingestion of the supplement with analysis of a complete blood count panel prior to and after the supplementation period. | within 26 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fenugreek extract, non-resistance trained