Muscle DamageNCT03318731
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
A study testing Sugar Pill, Fenugreek Extract, Low Dose and Fenugreek Extract, High Dose in people with Muscle Damage and Inflammation, run by University of Mary Hardin-Baylor at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Inflammation
- What is being tested?
- Sugar Pill, Fenugreek Extract, Low Dose and Fenugreek Extract, High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation on Healthy Non-resistance Trained Participants
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.
Read the 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.
- Conditions
- Muscle Damage, Inflammation
- Being tested
- Sugar Pill, Fenugreek Extract, Low Dose, Fenugreek Extract, High Dose
- Keywords
- fenugreek extract, non-resistance trained
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar PillOther
Taken orally in capsule form
Fenugreek Extract, Low DoseDietary supplement
Taken orally in capsule form
Fenugreek Extract, High DoseDietary supplement
Taken orally in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | 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. Receives: Other: Sugar Pill |
| Fenugreek Extract, Low Dose | Experimental | 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. Receives: Dietary Supplement: Fenugreek Extract, Low Dose |
| Fenugreek Extract, High Dose | Experimental | 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. Receives: Dietary Supplement: Fenugreek Extract, High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 26 days
Secondary outcomes (39)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 26 days
Effect of Fenugreek Extract on RDW %
v
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start21 Sep 2017
- Primary completion24 May 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups: placebo, 300mg dose (low) and 500mg dose (high)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary Hardin-Baylor
- Sponsor type
- University, hospital or other
- Collaborators
- Indus Biotech Ltd. Pvt.
- Responsible party
- Sponsor
- Investigators
- Lemuel W Taylor IV, PhD, Principal investigator, UMHB Human Performance Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318731
- Sponsor's protocol ID
- FNG-1
- Status last verified
- Sep 2019
- First submitted
- 2 Oct 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation on Healthy Non-resistance Trained Participants
- ClinicalTrials.gov ID
- NCT03318731
- Acronym / sponsor ID
- FNG-1
- Conditions
- Muscle Damage, Inflammation
- Keywords
- fenugreek extract, non-resistance trained
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Mary Hardin-BaylorUniversity, hospital or other
- Collaborators
- Indus Biotech Ltd. Pvt.
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three groups: placebo, 300mg dose (low) and 500mg dose (high)
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Other: Sugar PillMaltodextrin (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. |
| Fenugreek Extract, Low Dose | Experimental | Dietary Supplement: Fenugreek Extract, Low Dose300mg 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. |
| Fenugreek Extract, High Dose | Experimental | Dietary Supplement: Fenugreek Extract, High Dose500mg 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar PillTaken orally in capsule form | Other | Sugar Pill |
| Fenugreek Extract, Low DoseTaken orally in capsule form | Dietary supplement | Fenugreek Extract, Low Dose |
| Fenugreek Extract, High DoseTaken orally in capsule form | Dietary supplement | Fenugreek Extract, High Dose |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
39 secondary outcomes
Effect of Fenugreek Extract on Glucose mg/dL
Time frame: within 26 days
Effect of Fenugreek Extract on Urea Nitrogen (BUN) mg/Dl
Time frame: within 26 days
Effect of Fenugreek Extract on Creatinine mg/Dl
Time frame: within 26 days
Effect of Fenugreek Extract on eGFR Non-Afr. American mL/min/1.73m2
Time frame: within 26 days
Effect of Fenugreek Extract on eGFR African American mL/min/1.73m2
Time frame: within 26 days
Effect of Fenugreek Extract on BUN/Creatinine Ratio calculated
Time frame: within 26 days
Effect of Fenugreek Extract on Sodium mmol/L
Time frame: within 26 days
Effect of Fenugreek Extract on Potassium mmol/L
Time frame: within 26 days
Effect of Fenugreek Extract on Chloride mmol/L
Time frame: within 26 days
Effect of Fenugreek Extract on Carbon Dioxide mmol/L
Time frame: within 26 days
Effect of Fenugreek Extract on Calcium mg/Dl
Time frame: within 26 days
Effect of Fenugreek Extract on Protein, Total g/Dl
Time frame: within 26 days
Effect of Fenugreek Extract on Albumin g/dL
Time frame: within 26 days
Effect of Fenugreek Extract on Globulin g/Dl
Time frame: within 26 days
Effect of Fenugreek Extract on Albumin/Globulin Ratio calculated
Time frame: within 26 days
Effect of Fenugreek Extract on Bilirubin, Total mg/Dl
Time frame: within 26 days
Effect of Fenugreek Extract on Alkaline Phosphatase U/L
Time frame: within 26 days
Effect of Fenugreek Extract on Aspartate Aminotransferase U/L
Time frame: within 26 days
Effect of Fenugreek Extract on Alanine Aminotransferase U/L
Time frame: within 26 days
Effect of Fenugreek Extract on White Blood Cell Count thousand/uL
Time frame: within 26 days
Effect of Fenugreek Extract on Red Blood Cell Count million/uL
Time frame: within 26 days
Effect of Fenugreek Extract on Hemoglobin g/dL
Time frame: within 26 days
Effect of Fenugreek Extract on Hematocrit %
Time frame: within 26 days
Effect of Fenugreek Extract on MCV fL
Time frame: within 26 days
Effect of Fenugreek Extract on MCH pg
Time frame: within 26 days
Effect of Fenugreek Extract on MCHC g/dL
Time frame: within 26 days
Effect of Fenugreek Extract on RDW %
Time frame: within 26 days
Effect of Fenugreek Extract on Platelet Count thousand/uL
Time frame: within 26 days
Effect of Fenugreek Extract on MPV fL
Time frame: within 26 days
Effect of Fenugreek Extract on Absolute Neutrophils cells/uL
Time frame: within 26 days
Effect of Fenugreek Extract on Absolute Lymphocytes cells/uL
Time frame: within 26 days
Effect of Fenugreek Extract on Absolute Monocytes cells/uL
Time frame: within 26 days
Effect of Fenugreek Extract on Absolute Eosinophils cells/uL
Time frame: within 26 days
Effect of Fenugreek Extract on Absolute Basophils cells/uL
Time frame: within 26 days
Effect of Fenugreek Extract on Neutrophils %
Time frame: within 26 days
Effect of Fenugreek Extract on Lymphocytes %
Time frame: within 26 days
Effect of Fenugreek Extract on Monocytes %
Time frame: within 26 days
Effect of Fenugreek Extract on Eosinophils %
Time frame: within 26 days
Effect of Fenugreek Extract on Basophils %
Time frame: within 26 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lemuel W Taylor IV, PhD principal investigator
UMHB Human Performance Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar Pill, Fenugreek Extract, Low Dose and Fenugreek Extract, High Dose in people with Muscle Damage and Inflammation, run by University of Mary Hardin-Baylor at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Fenugreek Extract on Interleukin-1 (time frame: within 26 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.