Muscle DamageNCT05463835
RubusElite Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage
A study testing RubusElite, 'Protein rich' dairy beverage and 'Low Protein' dairy beverage in people with Muscle Damage and Muscle Soreness, run by University College Cork at 1 site in Ireland.
Trial summary
The RubusElite project is a multi-disciplinary project combining expertise in exercise science, nutrition, biochemistry, microbiology and food science across three institutions: University College Cork, Waterford Institute of Technology and Teagasc Food Research. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Muscle Soreness, Exercise Performance
- What is being tested?
- RubusElite, 'Protein rich' dairy beverage and 'Low Protein' dairy beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIreland
- Study dates
- 1 Aug 2022to 31 May 2023
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-45 Years of age • VO2peak between 35ml/kg/min and 55/ml/kg/min
Who cannot join
- Inability or unwillingness to discontinue use of any nutritional supplement or nutraceutical that may impact performance or recovery
- Have an ongoing injury which will impact their ability to exercise, or a history of landing related lower limb injury
- Being unwilling to consume a dairy product
- Any diagnosis of a psychiatric disorder or taking any anti-psychotic, anxiolytic or anti-depressant medication
- Any use of antibiotic medication within the previous two months or current use of prebiotic or probiotics.
- Any diagnosis of chronic coexisting illness [cardiovascular, gastrointestinal (GI) [to include functional GI disorders, inflammatory bowel disease, coeliac disease, lactose intolerance]
- Have a history of international sporting competition, or recent plyometric training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RubusElite Randomised Controlled Trial; Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage for Athletes and Physically Active Individuals
The RubusElite project is a multi-disciplinary project combining expertise in exercise science, nutrition, biochemistry, microbiology and food science across three institutions: University College Cork, Waterford Institute of Technology and Teagasc Food Research. This project has been funded by the Irish Department for Food, Agriculture and the Marines Food Institutional Research Measure (FIRM) initiative. The overarching aim of the RubusElite project is to provide an attractive, evidence-based performance and recovery food product for those undergoing frequent strenuous exercise in the form of a blackberry enriched, high protein dairy beverage. The process of developing this product will act as an exemplar model, providing best practice guidelines for the development of future functional foods in the performance nutrition space. This randomised controlled trial (RCT) will act as the ultimate test of efficacy of this functional food. It is envisaged that this RCT will assess the impact of a combined protein-polyphenol beverage on post-exercise recovery, exercise capacity, composition of the gut microbiome as well as central stress processing.
Read the detailed description
This study will take the form of a 3-arm single blind parallel proof-of-concept RCT with two arms acting as active intervention arms and the third acting as a control arm. Prospective participants will be provided with a participant information sheet and informed consent form prior to any involvement in the protocol. It will be made clear to participants from the outset that their involvement in this study is entirely voluntary and they will be free to withdraw from the study at any point without having to provide any reason or explanation and without any risk of repercussions, either direct or indirect. Participants will receive a signed copy of their informed consent forms for their records. Once an initial interest has been expressed by a volunteer, they will be invited to complete an initial Eligibility Screening Form to assess their initial eligibility. If successful in meeting the initial criteria, participants will then be invited to the Human Performance Laboratory at WIT for an initial screening visit. Upon arrival to the laboratory participants will be provided with an opportunity to ask questions related to the information provided in the information sheet followed by signing the informed consent form. During the screening visit participants will be required to fill out a readiness to exercise form to ensure they are in adequate health to perform maximal exercise of the VO2peak test (Appendix 4). Once all inclusion and exclusion criteria are met and the participant is happy to proceed with their involvement in the study, they will then be scheduled to return to the laboratory to complete a baseline visit. During the baseline visit participants will provide a series of baseline fasted biological samples, alongside baseline psychological assessments and undertake a baseline 15km cycling time trial performance test.
Participants will be randomised to their assigned intervention arm at the end of their baseline visit and will be provided with a six-day supply of their randomised treatment beverage and will be instructed to consume two servings per day of this beverage (RubusElite beverage, high protein milk or low protein milk) for the following six days. On day 7, participants will return to the Human Performance Laboratory to complete a 'test exercise day' where they will undergo a repeat 15km cycling time trial performance test followed by a bout of unaccustomed drop-jump exercise consisting of 100 repetitions total. Participants will then be provided with a further 3-days of their treatment beverage and requested to return to the Human Performance Laboratory at 24h and 48h post-'test-exercise day' for follow-up assessment. Participants will also receive a 72h follow up phone call from the research team in order to assess muscular recovery post EIMD induction. Participants will be made aware that this call marks the end of their study participation, they will be thanked for their attendance and contribution to this research and will be notified of the overall study findings as soon as they are available.
This study will be conducted in accordance with Good Clinical Practice protocols, the research team will be appropriately qualified with sufficient training on such.
- Conditions
- Muscle Damage, Muscle Soreness, Exercise Performance, Gut Microbiome, Stress, Anxiety
- Being tested
- RubusElite, 'Protein rich' dairy beverage, 'Low Protein' dairy beverage
- Medical subject headings
- Myalgia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RubusEliteDietary supplement
Each 500ml serving of this beverage will contain approximately 30g of milk protein alongside 750mg of polyphenols derived from blackberry puree. The study participant will consume 2 x 500ml per day which will contribute 60g protein and 1500mg polyphenols. No adverse effects associated with the consumption of dairy protein or berry fruits at the proposed intake levels have been reported to date.
'Protein rich' dairy beverageDietary supplement
This dairy beverage will contain approximately 30g of milk protein /500ml serving and will not contain polyphenols.
'Low Protein' dairy beverageDietary supplement
This product also contains no polyphenols and negligible protein.
| Study group | Role | What they receive |
|---|---|---|
| RubusElite dairy beverage | Experimental | The active treatment is a novel beverage, which has been formulated and developed by food Scientists at UCC. The RubusElite beverage is a science-led formulation of blackberry puree and high protein milk. Receives: Dietary Supplement: RubusElite |
| 'Protein rich' dairy beverage | Active comparator | The high protein dairy beverage will be a commercially available high protein milk which is commercially produced. Receives: Dietary Supplement: 'Protein rich' dairy beverage |
| 'Low Protein' dairy beverage | Sham comparator | The control beverage will be commercially available Taranis Dalia liquid commercially available low protein milk which will be purchased from the manufacturer for use in this study. Receives: Dietary Supplement: 'Low Protein' dairy beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Maximal Isometric Mid-thigh Pull Strength
Recovery of maximal muscle strength is assessed using an isometric mid-thigh pull following muscle damage inducing exercise. A fixed, immovable bar is set up at mid-thigh height directly above two force plates. While standing on the force plates the participant pulls on the bar as hard as possible for three continuous seconds and the maximal force produced is recorded in Newtons.
Measured: 48 hours post exercise
Recovery of Self-reported Muscle Soreness
Self-reported muscle soreness is measured on a muscle pain scale ranging from 0 to 10. A score of 0 represents no pain at all while a sore of 10 represents extreme pain.
Measured: 72 hours post exercise
Recovery of Biomarkers of Oxidative Stress in Blood Plasma
Oxidative stress measured by ELISA kit
Measured: 48 hours post exercise
Secondary outcomes (10)
Time to Complete 15km Cycling Time Trial
The time taken to cycle 15km on a stationary bike is measured in minutes and seconds.
Measured: 7 days
Heart Rate During 15km Cycling Time Trial
Heart rate is measured using a polar heart rate monitor at 5km, 10km and 15km during the 15km cycling time trial.
Measured: 7 days
Average Power Output During 15km Cycling Time Trial
The average power output is measured in watts by the stationary bike throughout the 15km cycling time trial.
Measured: 7 days
Blood Lactate Concentration in Blood During 15km Cycling Time Trial
Blood lactate is measured at 5km, 10km and 15km during the 15km cycling time trial. Blood is drawn from the earlobe and the blood lactate concentration is measured using a lactate pro meter.
Measured: 7 days
Perceived Stress
Perceived stress is measured by Cohens self-report perceived stress scale. Scores range from 0 to 40. Scores from 0-13 represent low stress levels, 14-26 represent moderate stress and score greater than 26 represent high levels of stress.
Measured: 10 days
Symptoms of Anxiety
Symptoms of anxiety are measured using the State Trait Anxiety Inventory. Scores for each of the forty items are summed giving a score ranging between 0 to 63. A score of 0 to 9 is normal, 10 to 18 is moderate anxiety, 19-29 is moderate to severe anxiety and a score above 29 is considered severe anxiety.
Measured: 10 days
Depressive Symptoms
Depressive symptoms are measured using the Beck Depression Inventory II. Outcome scores range form 0 to 63. A score between 0 and 13 is considered minimal range, 14 to 19 is mild, 20 to 28 is moderate and above 28 is severe.
Measured: 10 days
Gastrointestinal symptoms
Gastrointestinal symptoms are measured on line scales ranging from 0 to 100% where scores closer to 100% represent a negative outcome.
Measured: 10 days
Positive and Negative Affect Schedule
Assessed using the Positive and Negative Affect Schedule self-report questionnaire. The scale comprises of twenty items. Ten of the items measure positive emotion and ten measure negative emotion. The ten items measuring positive emotion are summed giving a score ranging from 10 to 50 with 50 indicating more of a positive affect. The ten items measuring negative emotion are summed giving a score ranging from 10 to 50 with 50 indicating more of a negative affect.
Measured: 10 days
Sleep Quality
Sleep quality is measured using the Pittsburgh Sleep Quality Index. The outcome is a score ranging from 0 to 21 with higher scores representing worse sleep quality.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Aug 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will take the form of a 3-arm single blind parallel proof-of-concept RCT with two arms acting as active intervention arms and the third acting as a control arm. This study will use non-random convenience sampling. This sample will be obtained from a combination of sources including the WIT arena, the WIT student population as well being advertised on social media by the researcher, participants of local sporting clubs in the Southeast of Ireland who may be eligible may also be approached.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- South East Technological University
- Responsible party
- Principal investigator, Dr. Alice Lucey, University College Cork
- Investigators
- Lorna Doyle, PhD, Principal investigator, Waterford Institute of TechnologyAlice Lucey, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463835
- Sponsor's protocol ID
- RubusEliteRCT
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RubusElite Randomised Controlled Trial; Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage for Athletes and Physically Active Individuals
- ClinicalTrials.gov ID
- NCT05463835
- Acronym / sponsor ID
- RubusEliteRCT
- Conditions
- Muscle Damage, Muscle Soreness, Exercise Performance, Gut Microbiome, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- South East Technological University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 19 Jul 2022 (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.
The RubusElite project is a multi-disciplinary project combining expertise in exercise science, nutrition, biochemistry, microbiology and food science across three institutions: University College Cork, Waterford Institute of Technology and Teagasc Food Research. This project has been funded by the Irish Department for Food, Agriculture and the Marines Food Institutional Research Measure (FIRM) initiative. The overarching aim of the RubusElite project is to provide an attractive, evidence-based performance and recovery food product for those undergoing frequent strenuous exercise in the form of a blackberry enriched, high protein dairy beverage. The process of developing this product will act as an exemplar model, providing best practice guidelines for the development of future functional foods in the performance nutrition space. This randomised controlled trial (RCT) will act as the ultimate test of efficacy of this functional food. It is envisaged that this RCT will assess the impact of a combined protein-polyphenol beverage on post-exercise recovery, exercise capacity, composition of the gut microbiome as well as central stress processing.
Detailed description
This study will take the form of a 3-arm single blind parallel proof-of-concept RCT with two arms acting as active intervention arms and the third acting as a control arm. Prospective participants will be provided with a participant information sheet and informed consent form prior to any involvement in the protocol. It will be made clear to participants from the outset that their involvement in this study is entirely voluntary and they will be free to withdraw from the study at any point without having to provide any reason or explanation and without any risk of repercussions, either direct or indirect. Participants will receive a signed copy of their informed consent forms for their records. Once an initial interest has been expressed by a volunteer, they will be invited to complete an initial Eligibility Screening Form to assess their initial eligibility. If successful in meeting the initial criteria, participants will then be invited to the Human Performance Laboratory at WIT for an initial screening visit. Upon arrival to the laboratory participants will be provided with an opportunity to ask questions related to the information provided in the information sheet followed by signing the informed consent form. During the screening visit participants will be required to fill out a readiness to exercise form to ensure they are in adequate health to perform maximal exercise of the VO2peak test (Appendix 4). Once all inclusion and exclusion criteria are met and the participant is happy to proceed with their involvement in the study, they will then be scheduled to return to the laboratory to complete a baseline visit. During the baseline visit participants will provide a series of baseline fasted biological samples, alongside baseline psychological assessments and undertake a baseline 15km cycling time trial performance test.
Participants will be randomised to their assigned intervention arm at the end of their baseline visit and will be provided with a six-day supply of their randomised treatment beverage and will be instructed to consume two servings per day of this beverage (RubusElite beverage, high protein milk or low protein milk) for the following six days. On day 7, participants will return to the Human Performance Laboratory to complete a 'test exercise day' where they will undergo a repeat 15km cycling time trial performance test followed by a bout of unaccustomed drop-jump exercise consisting of 100 repetitions total. Participants will then be provided with a further 3-days of their treatment beverage and requested to return to the Human Performance Laboratory at 24h and 48h post-'test-exercise day' for follow-up assessment. Participants will also receive a 72h follow up phone call from the research team in order to assess muscular recovery post EIMD induction. Participants will be made aware that this call marks the end of their study participation, they will be thanked for their attendance and contribution to this research and will be notified of the overall study findings as soon as they are available.
This study will be conducted in accordance with Good Clinical Practice protocols, the research team will be appropriately qualified with sufficient training on such.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study will take the form of a 3-arm single blind parallel proof-of-concept RCT with two arms acting as active intervention arms and the third acting as a control arm. This study will use non-random convenience sampling. This sample will be obtained from a combination of sources including the WIT arena, the WIT student population as well being advertised on social media by the researcher, participants of local sporting clubs in the Southeast of Ireland who may be eligible may also be approached.
| Arm | Type | Receives |
|---|---|---|
| RubusElite dairy beverage | Experimental | Dietary Supplement: RubusEliteThe active treatment is a novel beverage, which has been formulated and developed by food Scientists at UCC. The RubusElite beverage is a science-led formulation of blackberry puree and high protein milk. |
| 'Protein rich' dairy beverage | Active comparator | Dietary Supplement: 'Protein rich' dairy beverageThe high protein dairy beverage will be a commercially available high protein milk which is commercially produced. |
| 'Low Protein' dairy beverage | Sham comparator | Dietary Supplement: 'Low Protein' dairy beverageThe control beverage will be commercially available Taranis Dalia liquid commercially available low protein milk which will be purchased from the manufacturer for use in this study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between 18-45 Years of age • VO2peak between 35ml/kg/min and 55/ml/kg/min
Key exclusion criteria (7 listed)
- Inability or unwillingness to discontinue use of any nutritional supplement or nutraceutical that may impact performance or recovery
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 |
|---|---|---|
| RubusEliteEach 500ml serving of this beverage will contain approximately 30g of milk protein alongside 750mg of polyphenols derived from blackberry puree. The study participant will consume 2 x 500ml per day which will contribute 60g protein and 1500mg polyphenols. No adverse effects associated with the consumption of dairy protein or berry fruits at the proposed intake levels have been reported to date. | Dietary supplement | RubusElite dairy beverage |
| 'Protein rich' dairy beverageThis dairy beverage will contain approximately 30g of milk protein /500ml serving and will not contain polyphenols. | Dietary supplement | 'Protein rich' dairy beverage |
| 'Low Protein' dairy beverageThis product also contains no polyphenols and negligible protein. | Dietary supplement | 'Low Protein' dairy beverage |
Primary outcome
Recovery of Maximal Isometric Mid-thigh Pull Strength
Time frame: 48 hours post exercise
Recovery of maximal muscle strength is assessed using an isometric mid-thigh pull following muscle damage inducing exercise. A fixed, immovable bar is set up at mid-thigh height directly above two force plates. While standing on the force plates the participant pulls on the bar as hard as possible for three continuous seconds and the maximal force produced is recorded in Newtons.
Recovery of Self-reported Muscle Soreness
Time frame: 72 hours post exercise
Self-reported muscle soreness is measured on a muscle pain scale ranging from 0 to 10. A score of 0 represents no pain at all while a sore of 10 represents extreme pain.
Recovery of Biomarkers of Oxidative Stress in Blood Plasma
Time frame: 48 hours post exercise
Oxidative stress measured by ELISA kit
10 secondary outcomes
Time to Complete 15km Cycling Time Trial
Time frame: 7 days
Heart Rate During 15km Cycling Time Trial
Time frame: 7 days
Average Power Output During 15km Cycling Time Trial
Time frame: 7 days
Blood Lactate Concentration in Blood During 15km Cycling Time Trial
Time frame: 7 days
Perceived Stress
Time frame: 10 days
Symptoms of Anxiety
Time frame: 10 days
Depressive Symptoms
Time frame: 10 days
Gastrointestinal symptoms
Time frame: 10 days
Positive and Negative Affect Schedule
Time frame: 10 days
Sleep Quality
Time frame: 10 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 11 Jul 2023.
- 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.
Lorna Doyle, PhD principal investigator
Waterford Institute of Technology
Alice Lucey, PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RubusElite, 'Protein rich' dairy beverage and 'Low Protein' dairy beverage in people with Muscle Damage and Muscle Soreness, run by University College Cork at 1 site in Ireland.
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 7 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 11 Jul 2023. 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 Ireland. 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?
Recovery of Maximal Isometric Mid-thigh Pull Strength (time frame: 48 hours post exercise). The study lists 3 primary outcomes in all. 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 11 Jul 2023.