Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03318731
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Indus Biotech Ltd. Pvt.
Information provided by (Responsible Party):
University of Mary Hardin-Baylor

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Muscle Damage Inflammation Other: Sugar Pill Dietary Supplement: Fenugreek Extract, Low Dose Dietary Supplement: Fenugreek Extract, High Dose Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three groups: placebo, 300mg dose (low) and 500mg dose (high)
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Evaluation of the Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation on Healthy Non-resistance Trained Participants
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : May 24, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Sugar Pill
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
Taken orally in capsule form

Experimental: Fenugreek Extract, Low Dose
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
Taken orally in capsule form

Experimental: Fenugreek Extract, High 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




Primary Outcome Measures :
  1. Effect of Fenugreek Extract on Interleukin-1 [ Time Frame: within 26 days ]
    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.

  2. Effect of Fenugreek Extract on Creatine Kinase [ Time Frame: within 26 days ]
    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.

  3. Effect of Fenugreek Extract on Interleukin-6 [ Time Frame: within 26 days ]
    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.

  4. Effect of Fenugreek Extract on Tumor Necrosis Factor Alpha (TNF-α) [ Time Frame: within 26 days ]
    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.

  5. Effect of Fenugreek Extract on C-reactive protein [ Time Frame: within 26 days ]
    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.

  6. Effect of Fenugreek Extract on 3-methylhistidine [ Time Frame: within 26 days ]
    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.

  7. Effect of Fenugreek Extract on Lactate Dehydrogenase [ Time Frame: within 26 days ]
    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.


Secondary Outcome Measures :
  1. Effect of Fenugreek Extract on Glucose mg/dL [ Time Frame: within 26 days ]
    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.

  2. Effect of Fenugreek Extract on Urea Nitrogen (BUN) mg/Dl [ Time Frame: within 26 days ]
    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.

  3. Effect of Fenugreek Extract on Creatinine mg/Dl [ Time Frame: within 26 days ]
    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.

  4. Effect of Fenugreek Extract on eGFR Non-Afr. American mL/min/1.73m2 [ Time Frame: within 26 days ]
    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.

  5. Effect of Fenugreek Extract on eGFR African American mL/min/1.73m2 [ Time Frame: within 26 days ]
    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.

  6. Effect of Fenugreek Extract on BUN/Creatinine Ratio calculated [ Time Frame: within 26 days ]
    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.

  7. Effect of Fenugreek Extract on Sodium mmol/L [ Time Frame: within 26 days ]
    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.

  8. Effect of Fenugreek Extract on Potassium mmol/L [ Time Frame: within 26 days ]
    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.

  9. Effect of Fenugreek Extract on Chloride mmol/L [ Time Frame: within 26 days ]
    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.

  10. Effect of Fenugreek Extract on Carbon Dioxide mmol/L [ Time Frame: within 26 days ]
    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.

  11. Effect of Fenugreek Extract on Calcium mg/Dl [ Time Frame: within 26 days ]
    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.

  12. Effect of Fenugreek Extract on Protein, Total g/Dl [ Time Frame: within 26 days ]
    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.

  13. Effect of Fenugreek Extract on Albumin g/dL [ Time Frame: within 26 days ]
    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.

  14. Effect of Fenugreek Extract on Globulin g/Dl [ Time Frame: within 26 days ]
    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.

  15. Effect of Fenugreek Extract on Albumin/Globulin Ratio calculated [ Time Frame: within 26 days ]
    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.

  16. Effect of Fenugreek Extract on Bilirubin, Total mg/Dl [ Time Frame: within 26 days ]
    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.

  17. Effect of Fenugreek Extract on Alkaline Phosphatase U/L [ Time Frame: within 26 days ]
    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.

  18. Effect of Fenugreek Extract on Aspartate Aminotransferase U/L [ Time Frame: within 26 days ]
    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.

  19. Effect of Fenugreek Extract on Alanine Aminotransferase U/L [ Time Frame: within 26 days ]
    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.

  20. Effect of Fenugreek Extract on White Blood Cell Count thousand/uL [ Time Frame: within 26 days ]
    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.

  21. Effect of Fenugreek Extract on Red Blood Cell Count million/uL [ Time Frame: within 26 days ]
    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.

  22. Effect of Fenugreek Extract on Hemoglobin g/dL [ Time Frame: within 26 days ]
    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.

  23. Effect of Fenugreek Extract on Hematocrit % [ Time Frame: within 26 days ]
    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.

  24. Effect of Fenugreek Extract on MCV fL [ Time Frame: within 26 days ]
    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.

  25. Effect of Fenugreek Extract on MCH pg [ Time Frame: within 26 days ]
    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.

  26. Effect of Fenugreek Extract on MCHC g/dL [ Time Frame: within 26 days ]
    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.

  27. Effect of Fenugreek Extract on RDW % [ Time Frame: within 26 days ]
    v

  28. Effect of Fenugreek Extract on Platelet Count thousand/uL [ Time Frame: within 26 days ]
    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.

  29. Effect of Fenugreek Extract on MPV fL [ Time Frame: within 26 days ]
    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.

  30. Effect of Fenugreek Extract on Absolute Neutrophils cells/uL [ Time Frame: within 26 days ]
    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.

  31. Effect of Fenugreek Extract on Absolute Lymphocytes cells/uL [ Time Frame: within 26 days ]
    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.

  32. Effect of Fenugreek Extract on Absolute Monocytes cells/uL [ Time Frame: within 26 days ]
    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.

  33. Effect of Fenugreek Extract on Absolute Eosinophils cells/uL [ Time Frame: within 26 days ]
    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.

  34. Effect of Fenugreek Extract on Absolute Basophils cells/uL [ Time Frame: within 26 days ]
    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.

  35. Effect of Fenugreek Extract on Neutrophils % [ Time Frame: within 26 days ]
    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.

  36. Effect of Fenugreek Extract on Lymphocytes % [ Time Frame: within 26 days ]
    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.

  37. Effect of Fenugreek Extract on Monocytes % [ Time Frame: within 26 days ]
    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.

  38. Effect of Fenugreek Extract on Eosinophils % [ Time Frame: within 26 days ]
    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.

  39. Effect of Fenugreek Extract on Basophils % [ Time Frame: within 26 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318731


Locations
Layout table for location information
United States, Texas
UMHB Human Performance Lab
Belton, Texas, United States, 76513
Sponsors and Collaborators
University of Mary Hardin-Baylor
Indus Biotech Ltd. Pvt.
Investigators
Layout table for investigator information
Principal Investigator: Lemuel W Taylor IV, PhD UMHB Human Performance Lab

Layout table for additonal information
Responsible Party: University of Mary Hardin-Baylor
ClinicalTrials.gov Identifier: NCT03318731     History of Changes
Other Study ID Numbers: FNG-1
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Mary Hardin-Baylor:
fenugreek extract
non-resistance trained
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes
Fenugreek seed meal
Hypoglycemic Agents
Physiological Effects of Drugs