NCT06739408

Brief Summary

The goal of this clinical trial is to investigate the role of whole food protein source compared with supplement forms in enhancing response to resistance exercise training in moderately active participants. The main question it aims to answer: Whether wholefood protein (lean red meat) consumption is equivalent to supplementation in supporting muscle function and composition responses to resistance training? Whether wholefood protein consumption results in additional benefits to micronutrient status above that of supplementations? Researchers will compare both lean red meat and whey protein groups with an isocaloric maltodextrin control to see if protein intake enhanced response to resistance training.

  • Participants will be randomized to consume one of three treatments: (1) lean red meat, (2) a whey protein supplement, or (3) an isocaloric maltodextrin control beverage following each resistance training session.
  • Participants will complete a 12-week progressive resistance training programme consisting of 3 exercise sessions per week.
  • Participants will undergo skeletal muscle performance testing by way of Vertical jump height, isokinetic strength tests and estimated one repetition maximum tests prior to and following the 12-week resistance training programme.
  • Participants will undergo body composition assessment by way of bioelectrical impedance analysis, thigh muscle ultrasound and skinfold measurement prior to and following the 12-week resistance training programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed
Last Updated

April 29, 2026

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

November 25, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

proteinskeletal muscleresistance trainingfoodsupplementwheymeat

Outcome Measures

Primary Outcomes (1)

  • Isokinetic Dynamometry

    Change in primary leg Isokinetic lower limb strength will be measured using an isokinetic dynamometer (Biodex).

    12-weeks from pre to post resistance training programme

Secondary Outcomes (9)

  • Change to Fat Free Mass

    12-weeks from pre to post resistance training programme

  • Thigh Muscle Ultrasound

    12-weeks from pre to post resistance training programme

  • 4-Site Skinfold Thickness

    12-weeks from pre to post resistance training programme

  • Vertical Jump Height

    12-weeks from pre to post resistance training programme

  • Dietary Intake

    12-weeks from pre to post resistance training programme

  • +4 more secondary outcomes

Study Arms (3)

Lean Red Meat

EXPERIMENTAL

Cooked lean beef to provide approx 30g protein and isocalorically matched to be consumed 3x per week immediately following each resistance training session

Dietary Supplement: Lean red meat

Whey Protein

ACTIVE COMPARATOR

Whey protein to contain 30g of protein and isocalorically matched to be consumed 3x weekly immediately following each resistance training session

Dietary Supplement: Whey protein

Maltodextrin

PLACEBO COMPARATOR

Isocalorically matched but providing 0g protein to be consumed 3x per week immediately following each resistance training session

Dietary Supplement: Maltodextrin (Placebo)

Interventions

Lean red meatDIETARY_SUPPLEMENT

30g of protein from lean beef.

Lean Red Meat
Whey proteinDIETARY_SUPPLEMENT

Whey protein to provide 30g protein

Whey Protein
Maltodextrin (Placebo)DIETARY_SUPPLEMENT

Maltodextrin, to provide 0g protein but matched isocalorically

Maltodextrin

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a. Aged between 18 to 35 years old. b. Have completed either no or low level only resistance training in the previous 6 months.
  • c. Are not using any protein or performance/recovery enhancing supplements or willing to stop use for duration of the study.
  • d. Willing to consume study treatment for duration of the study. e. Willing to perform resistance training. f. Must be able and willing to provide written informed consent to participate.

You may not qualify if:

  • Have any notable health concern or disability which may conceivably increase risk to the participant and/or affect outcomes.
  • Has performed resistance training in the past 6 months at a moderate or high level.
  • Is a smoker.
  • Is unwilling or unable to perform full body resistance training.
  • Is pregnant or planning to become pregnant during the study period.
  • Has a food allergy or intolerance that may place participant at risk to consume any of the study treatments.
  • Is post-menopausal or currently undergoing menopause.
  • Follows a vegetarian or meat-avoidant diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Studies Unit, University College Cork

Cork, Co. Cork, T12 CY82, Ireland

Location

MeSH Terms

Interventions

Whey Proteinsmaltodextrin

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 18, 2024

Study Start

January 21, 2025

Primary Completion

September 22, 2025

Study Completion

October 17, 2025

Last Updated

April 29, 2026

Record last verified: 2025-11

Locations