NCT03318731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

October 2, 2017

Last Update Submit

September 24, 2019

Conditions

Muscle DamageInflammation

Keywords

fenugreek extractnon-resistance trained

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • Effect of Fenugreek Extract on Tumor Necrosis Factor Alpha (TNF-α)

    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

  • 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

  • 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

  • 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 Outcomes (39)

  • Effect of Fenugreek Extract on Glucose mg/dL

    within 26 days

  • Effect of Fenugreek Extract on Urea Nitrogen (BUN) mg/Dl

    within 26 days

  • Effect of Fenugreek Extract on Creatinine mg/Dl

    within 26 days

  • Effect of Fenugreek Extract on eGFR Non-Afr. American mL/min/1.73m2

    within 26 days

  • Effect of Fenugreek Extract on eGFR African American mL/min/1.73m2

    within 26 days

  • +34 more secondary outcomes

Study Arms (3)

Sugar Pill

PLACEBO COMPARATOR

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.

Other: Sugar Pill

Fenugreek Extract, Low Dose

EXPERIMENTAL

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.

Dietary Supplement: Fenugreek Extract, Low Dose

Fenugreek Extract, High Dose

EXPERIMENTAL

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.

Dietary Supplement: Fenugreek Extract, High Dose

Interventions

Sugar PillOTHER

Taken orally in capsule form

Sugar Pill
Fenugreek Extract, Low DoseDIETARY_SUPPLEMENT

Taken orally in capsule form

Fenugreek Extract, Low Dose
Fenugreek Extract, High DoseDIETARY_SUPPLEMENT

Taken orally in capsule form

Fenugreek Extract, High Dose

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMHB Human Performance Lab

Belton, Texas, 76513, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Sugarsfenugreek seed meal

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Lemuel W Taylor IV, PhD

    UMHB Human Performance Lab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Three groups: placebo, 300mg dose (low) and 500mg dose (high)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 24, 2017

Study Start

September 21, 2017

Primary Completion

May 24, 2019

Study Completion

August 30, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)