Clinical trial NCT03318731: Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
Official title: Evaluation of the Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation on Healthy Non-resistance Trained Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Damage
Inflammation
Keywords: fenugreek extract
non-resistance trained
Lead sponsor: University of Mary Hardin-Baylor
Sponsor class: OTHER
Collaborators: name: Indus Biotech Ltd. Pvt.
First posted: 2017-10-24
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups: placebo, 300mg dose (low) and 500mg dose (high)
Primary purpose: OTHER

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.

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.

Eligibility 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;

Primary outcomes:
measure: Effect of Fenugreek Extract on Interleukin-1
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Creatine Kinase
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Interleukin-6
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Tumor Necrosis Factor Alpha (TNF-α)
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on C-reactive protein
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on 3-methylhistidine
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Lactate Dehydrogenase
timeFrame: within 26 days
Secondary outcomes:
measure: Effect of Fenugreek Extract on Glucose mg/dL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Urea Nitrogen (BUN) mg/Dl
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Creatinine mg/Dl
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on eGFR Non-Afr. American mL/min/1.73m2
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on eGFR African American mL/min/1.73m2
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on BUN/Creatinine Ratio calculated
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Sodium mmol/L
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Potassium mmol/L
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Chloride mmol/L
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Carbon Dioxide mmol/L
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Calcium mg/Dl
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Protein, Total g/Dl
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Albumin g/dL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Globulin g/Dl
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Albumin/Globulin Ratio calculated
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Bilirubin, Total mg/Dl
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Alkaline Phosphatase U/L
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Aspartate Aminotransferase U/L
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Alanine Aminotransferase U/L
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on White Blood Cell Count thousand/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Red Blood Cell Count million/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Hemoglobin g/dL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Hematocrit %
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on MCV fL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on MCH pg
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on MCHC g/dL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on RDW %
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Platelet Count thousand/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on MPV fL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Absolute Neutrophils cells/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Absolute Lymphocytes cells/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Absolute Monocytes cells/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Absolute Eosinophils cells/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Absolute Basophils cells/uL
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Neutrophils %
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Lymphocytes %
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Monocytes %
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Eosinophils %
timeFrame: within 26 days
measure: Effect of Fenugreek Extract on Basophils %
timeFrame: within 26 days
Other outcomes:
Locations:
city: Belton
country: United States
facility: UMHB Human Performance Lab
state: Texas
Study officials:
affiliation: UMHB Human Performance Lab
name: Lemuel W Taylor IV, PhD
role: PRINCIPAL_INVESTIGATOR
References: