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

NCT ID: NCT03318731

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2019-08-30

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.

Conditions

Muscle Damage; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: OTHER

Taken orally in capsule form

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.

Group Type: EXPERIMENTAL

Fenugreek Extract, Low Dose

Intervention Type: DIETARY_SUPPLEMENT

Taken orally in capsule form

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.

Group Type: EXPERIMENTAL

Fenugreek Extract, High Dose

Intervention Type: DIETARY_SUPPLEMENT

Taken orally in capsule form

Interventions

Sugar Pill

Taken orally in capsule form

Intervention Type: OTHER

Fenugreek Extract, Low Dose

Taken orally in capsule form

Intervention Type: DIETARY_SUPPLEMENT

Fenugreek Extract, High Dose

Taken orally in capsule form

Intervention Type: DIETARY_SUPPLEMENT

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indus Biotech Ltd. Pvt.

UNKNOWN

Sponsor Role: collaborator

University of Mary Hardin-Baylor

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lemuel W Taylor IV, PhD

Role: PRINCIPAL_INVESTIGATOR

UMHB Human Performance Lab

Locations

UMHB Human Performance Lab

Belton, Texas, United States

Countries

United States

Other Identifiers

FNG-1

Identifier Type: -

Identifier Source: org_study_id