Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
Condition: Muscle Damage; Inflammation
MeSH terms: Inflammation
Study type: Interventional

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.
    

Intervention name(s): Sugar Pill; Fenugreek Extract, Low Dose; Fenugreek Extract, High Dose
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): Taken orally in capsule form; Taken orally in capsule form; Taken orally in capsule form
Intervention MeSH terms: Fenugreek seed meal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups: placebo, 300mg dose (low) and 500mg dose (high)
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: fenugreek extract; non-resistance trained