An interventional study of Sugar Pill and Fenugreek Extract, Low Dose in Muscle Damage and Inflammation, sponsored by University of Mary Hardin-Baylor. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by University of Mary Hardin-Baylor · Not applicable, Interventional, and Other
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.
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of Mary Hardin-Baylor is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Taken orally in capsule form
Taken orally in capsule form
Taken orally in capsule form
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: within 26 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: within 26 days
Effect of Fenugreek Extract on RDW %
v
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: within 26 days
Plan to share: No
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Ran from Sep 2017 to primary completion in May 2019, 20 months.
Of 877 non-industry interventional studies with no phase under Inflammation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 20 months is above that.
Counting every sponsor, half of 924 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Mary Hardin-Baylor