RubusElite Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage

NCT ID: NCT05463835

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-05-31

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.

Conditions

Muscle Damage; Muscle Soreness; Exercise Performance; Gut Microbiome; Stress; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RubusElite dairy beverage

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.

Group Type: EXPERIMENTAL

RubusElite

Intervention Type: DIETARY_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 beverage

The high protein dairy beverage will be a commercially available high protein milk which is commercially produced.

Group Type: ACTIVE_COMPARATOR

'Protein rich' dairy beverage

Intervention Type: DIETARY_SUPPLEMENT

This dairy beverage will contain approximately 30g of milk protein /500ml serving and will not contain polyphenols.

'Low Protein' dairy beverage

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.

Group Type: SHAM_COMPARATOR

'Low Protein' dairy beverage

Intervention Type: DIETARY_SUPPLEMENT

This product also contains no polyphenols and negligible protein.

Interventions

RubusElite

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.

Intervention Type: DIETARY_SUPPLEMENT

'Protein rich' dairy beverage

This dairy beverage will contain approximately 30g of milk protein /500ml serving and will not contain polyphenols.

Intervention Type: DIETARY_SUPPLEMENT

'Low Protein' dairy beverage

This product also contains no polyphenols and negligible protein.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

South East Technological University

UNKNOWN

Sponsor Role: collaborator

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alice Lucey

Project Co-ordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorna Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

Waterford Institute of Technology

Alice Lucey, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Locations

Waterford Institute of Technology

Waterford, Munster, Ireland

Countries

Ireland

Other Identifiers

RubusEliteRCT

Identifier Type: -

Identifier Source: org_study_id