Inflammation Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation on Healthy Non-resistance Trained Participants
Verified date | September 2019 |
Source | University of Mary Hardin-Baylor |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 30, 2019 |
Est. primary completion date | May 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
United States | UMHB Human Performance Lab | Belton | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Mary Hardin-Baylor | Indus Biotech Ltd. Pvt. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Effect of Fenugreek Extract on Tumor Necrosis Factor Alpha (TNF-a) | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Effect of Fenugreek Extract on RDW % | v | within 26 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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