HealthySPADENCT02980900
The Effect of Protein Ingestion on the Recovery of Skeletal Muscle Function Following Eccentric Exercise.
A study testing Post exercise protein-polyphenol supplement and Pre bed protein-polyphenol supplement in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The present study will assess the effect of the type and timing of protein ingestion 6 days prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Post exercise protein-polyphenol supplement and Pre bed protein-polyphenol supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2017to 1 Aug 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women who are generally healthy and recreationally active
Who cannot join
- Active cardiovascular disease or hypertension
- Diagnosed metabolic impairment
- Use of nutritional supplements
- Use of anti-inflammatory medications
- Habitual dietary protein intake of <0.8g/kg/day
- Musculoskeletal disorders
Trial locations and contacts
1 site in 1 country.
About this study
The present study will assess the effect of the type and timing of protein ingestion 6 days prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.
- Conditions
- Healthy
- Being tested
- Post exercise protein-polyphenol supplement, Post exercise placebo supplement, Pre bed protein-polyphenol supplement, Pre bed placebo supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post exercise protein-polyphenol supplementDietary supplement
Participants will ingest a post exercise protein-polyphenol supplement. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
Post exercise placebo supplementDietary supplement
Participants will ingest an isocaloric placebo supplement after exercise. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
Pre bed protein-polyphenol supplementDietary supplement
Participants will ingest a protein-polyphenol supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
Pre bed placebo supplementDietary supplement
Participants will ingest an isocaloric placebo supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
| Study group | Role | What they receive |
|---|---|---|
| Placebo supplement | Placebo comparator | Post exercise placebo supplement Pre bed placebo supplement Receives: Dietary Supplement: Post exercise placebo supplement; Dietary Supplement: Pre bed placebo supplement |
| Post exercise supplement | Active comparator | Post exercise protein-polyphenol supplement Pre bed placebo supplement Receives: Dietary Supplement: Post exercise protein-polyphenol supplement; Dietary Supplement: Pre bed placebo supplement |
| Pre bed supplement | Active comparator | Post exercise placebo supplement Pre bed protein-polyphenol supplement Receives: Dietary Supplement: Post exercise placebo supplement; Dietary Supplement: Pre bed protein-polyphenol supplement |
| Post exercise + pre bed supplement | Active comparator | Post exercise protein-polyphenol supplement Pre bed protein-polyphenol supplement Receives: Dietary Supplement: Post exercise protein-polyphenol supplement; Dietary Supplement: Pre bed protein-polyphenol supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic force production of the knee extensor muscles
Measured: 14 days
Secondary outcomes (4)
Muscle protein synthesis
Measured: 14 days
Thigh volume
Measured: 14 days
Perceived muscle soreness
Measured: 14 days
Isometric force production of the knee extensor muscles
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980900
- Sponsor's protocol ID
- 181739
- Acronym
- SPADE
- Status last verified
- Oct 2018
- First submitted
- 30 Nov 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jameson TSO, Pavis GF, Dirks ML, Lee BP, Abdelrahman DR, Murton AJ, Porter C, Alamdari N, Mikus CR, Wall BT, Stephens FB. Reducing NF-kappaB Signaling Nutritionally is Associated with Expedited Recovery of Skeletal Muscle Function After Damage. J Clin Endocrinol Metab. 2021 Jun 16;106(7):2057-2076. doi: 10.1210/clinem/dgab106.
PubMed 33710344
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Ingestion on the Recovery of Skeletal Muscle Function Following Eccentric Exercise.
- ClinicalTrials.gov ID
- NCT02980900
- Acronym / sponsor ID
- SPADE / 181739
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- 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.
The present study will assess the effect of the type and timing of protein ingestion 6 days prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo supplement | Placebo comparator | Dietary Supplement: Post exercise placebo supplement, Dietary Supplement: Pre bed placebo supplementPost exercise placebo supplement Pre bed placebo supplement |
| Post exercise supplement | Active comparator | Dietary Supplement: Post exercise protein-polyphenol supplement, Dietary Supplement: Pre bed placebo supplementPost exercise protein-polyphenol supplement Pre bed placebo supplement |
| Pre bed supplement | Active comparator | Dietary Supplement: Post exercise placebo supplement, Dietary Supplement: Pre bed protein-polyphenol supplementPost exercise placebo supplement Pre bed protein-polyphenol supplement |
| Post exercise + pre bed supplement | Active comparator | Dietary Supplement: Post exercise protein-polyphenol supplement, Dietary Supplement: Pre bed protein-polyphenol supplementPost exercise protein-polyphenol supplement Pre bed protein-polyphenol supplement |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women who are generally healthy and recreationally active
Key exclusion criteria (6 listed)
- Active cardiovascular disease or hypertension
- Diagnosed metabolic impairment
- Use of nutritional supplements
- Use of anti-inflammatory medications
- Habitual dietary protein intake of <0.8g/kg/day
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 |
|---|---|---|
| Post exercise protein-polyphenol supplementParticipants will ingest a post exercise protein-polyphenol supplement. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise. | Dietary supplement | Post exercise + pre bed supplement, Post exercise supplement |
| Post exercise placebo supplementParticipants will ingest an isocaloric placebo supplement after exercise. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise. | Dietary supplement | Placebo supplement, Pre bed supplement |
| Pre bed protein-polyphenol supplementParticipants will ingest a protein-polyphenol supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise. | Dietary supplement | Post exercise + pre bed supplement, Pre bed supplement |
| Pre bed placebo supplementParticipants will ingest an isocaloric placebo supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise. | Dietary supplement | Placebo supplement, Post exercise supplement |
Primary outcome
Isokinetic force production of the knee extensor muscles
Time frame: 14 days
4 secondary outcomes
Muscle protein synthesis
Time frame: 14 days
Thigh volume
Time frame: 14 days
Perceived muscle soreness
Time frame: 14 days
Isometric force production of the knee extensor muscles
Time frame: 14 days
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 16 Oct 2018.
- Derived from this study: PubMed 33710344Jameson TSO, Pavis GF, Dirks ML, Lee BP, Abdelrahman DR, Murton AJ, Porter C, Alamdari N, Mikus CR, Wall BT, Stephens FB. Reducing NF-kappaB Signaling Nutritionally is Associated with Expedited Recovery of Skeletal Muscle Function After Damage. J Clin Endocrinol Metab. 2021 Jun 16;106(7):2057-2076. doi: 10.1210/clinem/dgab106.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post exercise protein-polyphenol supplement and Pre bed protein-polyphenol supplement in people with Healthy, 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 1 inclusion and 6 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 16 Oct 2018. 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?
Isokinetic force production of the knee extensor muscles (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980900, which also lists 1 linked publication.
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 16 Oct 2018.