Clinical trial NCT05463835: RubusElite Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage
Official title: RubusElite Randomised Controlled Trial; Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage for Athletes and Physically Active Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Damage
Muscle Soreness
Exercise Performance
Gut Microbiome
Stress
Anxiety
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: South East Technological University
First posted: 2022-07-19
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Between 18-45 Years of age • VO2peak between 35ml/kg/min and 55/ml/kg/min

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recovery of Maximal Isometric Mid-thigh Pull Strength
timeFrame: 48 hours post exercise
measure: Recovery of Self-reported Muscle Soreness
timeFrame: 72 hours post exercise
measure: Recovery of Biomarkers of Oxidative Stress in Blood Plasma
timeFrame: 48 hours post exercise
Secondary outcomes:
measure: Time to Complete 15km Cycling Time Trial
timeFrame: 7 days
measure: Heart Rate During 15km Cycling Time Trial
timeFrame: 7 days
measure: Average Power Output During 15km Cycling Time Trial
timeFrame: 7 days
measure: Blood Lactate Concentration in Blood During 15km Cycling Time Trial
timeFrame: 7 days
measure: Perceived Stress
timeFrame: 10 days
measure: Symptoms of Anxiety
timeFrame: 10 days
measure: Depressive Symptoms
timeFrame: 10 days
measure: Gastrointestinal symptoms
timeFrame: 10 days
measure: Positive and Negative Affect Schedule
timeFrame: 10 days
measure: Sleep Quality
timeFrame: 10 days
Other outcomes:
Locations:
city: Waterford
country: Ireland
facility: Waterford Institute of Technology
state: Munster
Study officials:
affiliation: Waterford Institute of Technology
name: Lorna Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Cork
name: Alice Lucey, PhD
role: PRINCIPAL_INVESTIGATOR
References: