Clinical trial NCT06739408: Protein Source and Resistance Training
Official title: Investigation of Protein Source and Its Impact on Response to Resistance Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
No Condition
Keywords: protein
skeletal muscle
resistance training
food
supplement
whey
meat
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Background Protein supplements and particularly whey protein supplements are frequently consumed by athletes and recreationally active adults to achieve greater gains in muscle mass and strength as well as improved physical performance. Lean red meat has the equivalent essential amino acid and branched chain amino acids as whey protein, and additionally contains creatine, beta-alanine and several essential vitamins and minerals which are important for health and performance. Therefore, the preferential addition of lean red meat to the diet as opposed to whey protein supplements may provide the same and possibly greater benefits and would be in line with the recommended 'food first approach' endorsed by Sport Ireland and the World Anti-Doping Agency among others.

Aim The overall aim of this study is to explore whether lean red meat augments adaptation to resistance training in recreationally active young adults undergoing resistance training. Additionally, the investigators aim to investigate changes in nutritional intakes and status of selected micronutrients in response to increased consumption of lean red meat.

Methods

A total of n=72 recreationally active men and women (50% male) will be recruited to this single-blinded intervention study with a parallel design. 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 and will complete a 12-week resistance training programme.

Measurements: Body composition and muscle thickness will be measured using bioelectrical impedance analysis and ultrasound respectively. Additionally, skinfold measurements will be used to estimate body fat percentage. Vertical jump height, isokinetic strength and 1 repetition maximums will be completed to assess muscle contractile properties namely explosive and maximal strength. Blood pressure will also be measured at baseline and post intervention. Finally, dietary intake will be recorded at selected timepoints, and blood tests will be used to characterise status of selected micronutrients, blood lipids, and inflammation markers. All measures will be performed before and at the end of a 12-week resistance training intervention during which all participants will engage in resistance exercise 3 days per week and consume their assigned treatment on each of those training days.

Conclusion By investigating the impact of lean red meat on exercise adaptation and nutrition status of a number of selected micronutrients this study can contribute to the understanding of the role of lean red meat in performance nutrition. Additionally, this study can more broadly contribute to our understanding of the "food first" approach as it relates to recreationally active men and women.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Isokinetic Dynamometry
timeFrame: 12-weeks from pre to post resistance training programme
Secondary outcomes:
measure: Change to Fat Free Mass
timeFrame: 12-weeks from pre to post resistance training programme
measure: Thigh Muscle Ultrasound
timeFrame: 12-weeks from pre to post resistance training programme
measure: 4-Site Skinfold Thickness
timeFrame: 12-weeks from pre to post resistance training programme
measure: Vertical Jump Height
timeFrame: 12-weeks from pre to post resistance training programme
measure: Dietary Intake
timeFrame: 12-weeks from pre to post resistance training programme
measure: Change to LDL cholesterol
timeFrame: 12-weeks from pre to post resistance training programme
measure: Change to serum ferritin status
timeFrame: 12-weeks from pre to post resistance training programme
measure: Change to total score on SAGIS questionnaire
timeFrame: 12-weeks from pre to post resistance training programme
measure: Change to vitamin D status
timeFrame: 12-weeks from pre to post resistance training programme
Other outcomes:
Locations:
city: Cork City
country: Ireland
facility: Human Nutrition Studies Unit, University College Cork
state: Co. Cork
Study officials:
References: