RubusElite Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage
Condition: Muscle Damage; Muscle Soreness; Exercise Performance; Gut Microbiome; Stress; Anxiety
MeSH terms: Myalgia
Study type: Interventional

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.
    

Intervention name(s): RubusElite; 'Protein rich' dairy beverage; 'Low Protein' dairy beverage
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; This dairy beverage will contain approximately 30g of milk protein /500ml serving and will not contain polyphenols.; This product also contains no polyphenols and negligible protein.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment