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Supplemental Protein And Resistance Training Adaptations (SPARTA)

Primary Purpose

Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo beverage
Protein-polyphenol beverage
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertrophy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and Female
  • 18 - 40 years of age
  • Recreationally active

Exclusion Criteria:

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes). Such impairments can affect skeletal muscle metabolism
  • Any diagnosed cardiovascular disease or hypertension
  • Use of nutritional supplements (e.g. protein, polyphenols, vitamins, antioxidants) as use of nutritional supplements during the study period may interfere with the physiological responses to the supplements of interest administered in this study.
  • Habitual dietary protein intake <0.8 g/kg/day or >1.6 g/kg/day as calculated with a three day diet diary. Habitually low protein may impair adaptations to resistance exercise training and a habitually excessive protein intake may negate the benefit of protein supplementation.
  • Current musculoskeletal injury that may impair exercise performance or may be exacerbated due to this studies exercise protocol.
  • Resistance trained (participating in structured resistance exercise 3 or more times per week for >6 months), endurance trained (participating in structured endurance exercise for >6h per week for >6 months), or sedentary participants as these are not the populations of interest.
  • Chronic use of anti-inflammatory medicines prior to the study and unwillingness to refrain from taking anti-inflammatory medications during the study as these medications may affect skeletal muscle metabolism and/or adaptation to exercise.
  • Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe that they have an allergy to milk or milk products, crustacean shellfish, tree nuts, or peanuts
  • Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
  • Individuals with non removable metallic implants (including heart pacemaker, cochlea implants, medication pumps, surgical clips, plates or screws) or claustrophobia

Sites / Locations

  • University of Exeter

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Protein-Polyphenol supplement

Arm Description

Placebo beverage

Protein-polyphenol beverage

Outcomes

Primary Outcome Measures

Change in cross-sectional area of quadriceps muscle group
The cross-sectional area of the muscles comprising the thigh after 30 training sessions will be compared to pre-training values. This will be measured using MRI.

Secondary Outcome Measures

Change in quadriceps muscle group volume
The volume of the muscles comprising the thigh after 30 training sessions will be compared to pre-training values. This will be measured using MRI.
Change in knee extensor isokinetic total work
Bilateral knee extensor isokinetic total work will be assessed before and after the training program by quantifying work completed over 30 isokinetic quadriceps contractions on an isokinetic dynamometer.
Change in maximal isometric peak torque
Knee extensor isometric peak torque will be assessed before and after the training program using an isokinetic dynamometer.
Change in maximal isokinetic peak torque
Knee extensor isokinetic peak torque over 3 repetitions will be assessed before and after the training program using an isokinetic dynamometer.
Change in muscle protein synthesis assessed using the stable isotope Deuterium Oxide
The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change over 48 hours will be measured pre- and post-training to calculate a fractional synthesis rate (% day).
Perceived quadriceps muscle soreness:
Soreness will be assessed at the start of each training session using a validated visual analogue scale (VAS)

Full Information

First Posted
April 16, 2019
Last Updated
March 30, 2020
Sponsor
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT03918395
Brief Title
Supplemental Protein And Resistance Training Adaptations
Acronym
SPARTA
Official Title
Does Protein and Polyphenol Supplementation Augment Adaptations to 30 Sessions of Resistance Exercise Training in Healthy Males and Females Compared to an Isoenergetic Placebo Supplement?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 21, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic resistance training has been shown to increase muscle cross-sectional area, volume and strength. Individuals participating in a resistance training program may wish to consume protein supplements to aid recovery and maximise adaptation. Furthermore, antioxidants have been shown to aid recovery from acute bouts of exercise. However, the effect of antioxidants combined with protein on long term-training adaptation is not fully understood. This study will combine measures of muscle size, muscle strength and function, and the underlying changes in muscle metabolism in order to assess the effect of consuming a combined protein-antioxidant supplement during a 30 session resistance training program.
Detailed Description
Supplemental protein ingestion is an established method for augmenting gains in fat free mass, muscle strength and muscle cross sectional area following a period of resistance exercise training. In addition to protein, supplements high in polyphenols such as berry and pomegranate extract are believed to be an effective method of reducing soreness and facilitating recovery following a single bout of resistance exercise. However, whilst polyphenols are shown to facilitate recovery from a single session of resistance exercise, their effect on adaptations to repeated bouts of resistance exercise are unknown. Asking this question will allow a detailed investigation of the mechanisms by which protein-polyphenol ingestion may affect adaptations to resistance exercise training when compared to a non protein or polyphenol containing placebo, which is an important yet underexplored area

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo beverage
Arm Title
Protein-Polyphenol supplement
Arm Type
Active Comparator
Arm Description
Protein-polyphenol beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo beverage
Intervention Description
A placebo beverage will be consumed both post-exercise and pre-bed
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein-polyphenol beverage
Intervention Description
A protein-polyphenol beverage will be consumed both post-exercise and pre-bed
Primary Outcome Measure Information:
Title
Change in cross-sectional area of quadriceps muscle group
Description
The cross-sectional area of the muscles comprising the thigh after 30 training sessions will be compared to pre-training values. This will be measured using MRI.
Time Frame
After 30 training sessions (approx. 10 weeks)
Secondary Outcome Measure Information:
Title
Change in quadriceps muscle group volume
Description
The volume of the muscles comprising the thigh after 30 training sessions will be compared to pre-training values. This will be measured using MRI.
Time Frame
After 30 training sessions (approx. 10 weeks)
Title
Change in knee extensor isokinetic total work
Description
Bilateral knee extensor isokinetic total work will be assessed before and after the training program by quantifying work completed over 30 isokinetic quadriceps contractions on an isokinetic dynamometer.
Time Frame
After 30 training sessions (approx. 10 weeks)
Title
Change in maximal isometric peak torque
Description
Knee extensor isometric peak torque will be assessed before and after the training program using an isokinetic dynamometer.
Time Frame
After 30 training sessions (approx. 10 weeks)
Title
Change in maximal isokinetic peak torque
Description
Knee extensor isokinetic peak torque over 3 repetitions will be assessed before and after the training program using an isokinetic dynamometer.
Time Frame
After 30 training sessions (approx. 10 weeks)
Title
Change in muscle protein synthesis assessed using the stable isotope Deuterium Oxide
Description
The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change over 48 hours will be measured pre- and post-training to calculate a fractional synthesis rate (% day).
Time Frame
After 30 training sessions (approx. 10 weeks)
Title
Perceived quadriceps muscle soreness:
Description
Soreness will be assessed at the start of each training session using a validated visual analogue scale (VAS)
Time Frame
After 30 training sessions (approx. 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and Female 18 - 40 years of age Recreationally active Exclusion Criteria: Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes). Such impairments can affect skeletal muscle metabolism Any diagnosed cardiovascular disease or hypertension Use of nutritional supplements (e.g. protein, polyphenols, vitamins, antioxidants) as use of nutritional supplements during the study period may interfere with the physiological responses to the supplements of interest administered in this study. Habitual dietary protein intake <0.8 g/kg/day or >1.6 g/kg/day as calculated with a three day diet diary. Habitually low protein may impair adaptations to resistance exercise training and a habitually excessive protein intake may negate the benefit of protein supplementation. Current musculoskeletal injury that may impair exercise performance or may be exacerbated due to this studies exercise protocol. Resistance trained (participating in structured resistance exercise 3 or more times per week for >6 months), endurance trained (participating in structured endurance exercise for >6h per week for >6 months), or sedentary participants as these are not the populations of interest. Chronic use of anti-inflammatory medicines prior to the study and unwillingness to refrain from taking anti-inflammatory medications during the study as these medications may affect skeletal muscle metabolism and/or adaptation to exercise. Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe that they have an allergy to milk or milk products, crustacean shellfish, tree nuts, or peanuts Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients Individuals with non removable metallic implants (including heart pacemaker, cochlea implants, medication pumps, surgical clips, plates or screws) or claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Stephens, PhD
Organizational Affiliation
University of Exeter
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Exeter
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Supplemental Protein And Resistance Training Adaptations

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