HypertrophySPARTANCT03918395
Supplemental Protein And Resistance Training Adaptations
A study testing Protein-polyphenol beverage in people with Hypertrophy, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy
- What is being tested?
- Protein-polyphenol beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2018to 21 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and Female
- 18 - 40 years of age
- Recreationally active
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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
- Conditions
- Hypertrophy
- Being tested
- Placebo beverage, Protein-polyphenol beverage
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo beverageDietary supplement
A placebo beverage will be consumed both post-exercise and pre-bed
Protein-polyphenol beverageDietary supplement
A protein-polyphenol beverage will be consumed both post-exercise and pre-bed
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo beverage Receives: Dietary Supplement: Placebo beverage |
| Protein-Polyphenol supplement | Active comparator | Protein-polyphenol beverage Receives: Dietary Supplement: Protein-polyphenol beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 30 training sessions (approx. 10 weeks)
Secondary outcomes (6)
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.
Measured: After 30 training sessions (approx. 10 weeks)
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.
Measured: After 30 training sessions (approx. 10 weeks)
Change in maximal isometric peak torque
Knee extensor isometric peak torque will be assessed before and after the training program using an isokinetic dynamometer.
Measured: After 30 training sessions (approx. 10 weeks)
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.
Measured: After 30 training sessions (approx. 10 weeks)
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).
Measured: After 30 training sessions (approx. 10 weeks)
Perceived quadriceps muscle soreness:
Soreness will be assessed at the start of each training session using a validated visual analogue scale (VAS)
Measured: After 30 training sessions (approx. 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Sep 2018
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Stephens, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918395
- Sponsor's protocol ID
- 171206/B/09
- Acronym
- SPARTA
- Status last verified
- Mar 2020
- First submitted
- 16 Apr 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03918395
- Acronym / sponsor ID
- SPARTA / 171206/B/09
- Conditions
- Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo beveragePlacebo beverage |
| Protein-Polyphenol supplement | Active comparator | Dietary Supplement: Protein-polyphenol beverageProtein-polyphenol beverage |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and Female
- 18 - 40 years of age
- Recreationally active
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo beverageA placebo beverage will be consumed both post-exercise and pre-bed | Dietary supplement | Placebo |
| Protein-polyphenol beverageA protein-polyphenol beverage will be consumed both post-exercise and pre-bed | Dietary supplement | Protein-Polyphenol supplement |
Primary outcome
Change in cross-sectional area of quadriceps muscle group
Time frame: After 30 training sessions (approx. 10 weeks)
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.
6 secondary outcomes
Change in quadriceps muscle group volume
Time frame: After 30 training sessions (approx. 10 weeks)
Change in knee extensor isokinetic total work
Time frame: After 30 training sessions (approx. 10 weeks)
Change in maximal isometric peak torque
Time frame: After 30 training sessions (approx. 10 weeks)
Change in maximal isokinetic peak torque
Time frame: After 30 training sessions (approx. 10 weeks)
Change in muscle protein synthesis assessed using the stable isotope Deuterium Oxide
Time frame: After 30 training sessions (approx. 10 weeks)
Perceived quadriceps muscle soreness:
Time frame: After 30 training sessions (approx. 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Stephens, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-polyphenol beverage in people with Hypertrophy, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cross-sectional area of quadriceps muscle group (time frame: After 30 training sessions (approx. 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.