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

University of Mary Hardin-Baylor

Status

Completed

Conditions

Inflammation

Muscle Damage

Treatments

Dietary Supplement: Fenugreek Extract, Low Dose

Dietary Supplement: Fenugreek Extract, High Dose

Other: Sugar Pill

Study type

Interventional

Funder types

Other

Identifiers

NCT03318731

FNG-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups, including a placebo group

Sugar Pill

Placebo Comparator group

Description:

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.

Treatment:

Other: Sugar Pill

Fenugreek Extract, Low Dose

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fenugreek Extract, Low Dose

Fenugreek Extract, High Dose

Experimental group

Description:

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.