- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05827666
The Effect of Dairy and Dairy-Free Alternative Beverages on Post-Exercise Anabolism in Active Youth (PBS)
Study Overview
Status
Conditions
Detailed Description
The growth and development of lean body mass (LBM) (e.g., muscle and bone) is vital to not only support health and performance across the lifespan but also, reduce the prevalence of metabolic disorders later in life, such as osteoporosis and sarcopenia. Active youth who regularly perform moderate-to-vigorous physical activity (MVPA) have superior increases LBM and muscle strength compared to their sedentary counterparts. LBM is regulated by the process of protein breakdown (PB), where old or damaged proteins are broken down releasing their constituent amino acids (AA), as well as protein synthesis (PS), a process by which new proteins are made by linking constituent AAs together. When rates of PS exceed rates of PB (PS>PB), a positive net protein balance is achieved, ultimately facilitating the accretion of LBM. Contrarily, if PB>PS, net protein balance is negative, leading to the loss of LBM.
Assuming total energy intakes are met, to meet the metabolic demands of an active lifestyle, dietary protein is a prime anabolic stimulus. This macronutrient facilitates the growth of lean tissues by providing the AA 'building blocks' to support the synthesis of muscle and other body proteins. Physical activity (PA) is a second pre-eminent factor contributing to the growth of LBM. Following exercise, in the absence of dietary protein ingestion, net protein balance is negative. However, post-exercise protein consumption facilitates a positive net protein balance, which when repeated over time, can contribute to the accretion of LBM. Youth who engage in high levels of PA have greater LBM compared to their sedentary counterparts. Thus, it is important to capitalize on the optimal nutritional and exercise interventions to support a positive net protein balance, an acute marker of growth, especially in vulnerable populations, such as children.
In children, milk protein ingestion has been shown to stimulate whole-body PS, resulting in a positive whole-body net protein balance. In adults, dairy proteins lead to superior post-exercise recovery and PS compared to non-dairy alternatives. Most research to date examining the post-prandial protein synthesis responses to plant-based protein sources have encompassed isolated protein sources. However, there is currently a paucity of research examining the effect of the whole-food matrix of plant-based protein sources on whole-body protein metabolism in active youth. Furthermore, the pubertal growth spurt is characterized by rapid accumulation of LBM that is only surpassed by the first year of life. This LBM, which is enhanced by an active lifestyle, must be supported by adequate energy and protein ingestion. Therefore, it is necessary to determine the post-exercise anabolic effect of dairy and non-dairy whole foods on markers of LBM growth and whole-body protein metabolism, especially in children, an under-researched population.
The current project will employ the indicator amino acid oxidation (IAAO) methodology to determine the protein/AA intake that minimizes oxidation of the indicator AA, while maximizing PS. The oxidation of the indicator AA is minimized by ingesting an adequate proportion of AA, and/or consuming nutritionally complete protein sources. The main objective of the present study is to determine the effect of energy-matched dairy and non-dairy milk alternatives on whole-body protein synthesis in active youth following exercise.
Aim 1: To determine the effect of dairy (2% milk) and non-dairy milk alternatives (soy, rice, and almond 'milk' beverages) on whole-body PS following a bout of intermittent exercise in children, adolescent males, and adolescent females.
Hypothesis 1: Whole body PS will be greatest after ingestion of dairy milk compared to isocaloric (i.e., equal energy amount) non-dairy alternatives, due to the greater and/or higher amount of quality dietary protein. Regardless of sex, adolescents are expected to have greater PS due to their heightened anabolic sensitivity, compared to children.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel R Moore, PhD
- Phone Number: 4169464088
- Email: dr.moore@utoronto.ca
Study Contact Backup
- Name: Hugo JW Fung, PhD (c)
- Email: hugojernwai.fung@utoronto.ca
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5S 2C9
- Recruiting
- Goldring Centre for High Performance and Sport
-
Contact:
- Daniel Moore, PhD
- Phone Number: 4169464088
- Email: dr.moore@utoronto.ca
-
Contact:
- Nicki Pourhashemi, BSc
- Phone Number: 6478817899
- Email: nicki.pourhashemi@mail.utoronto.ca
-
Sub-Investigator:
- Hugo Fung, MSc
-
Sub-Investigator:
- Ines Kortebi, MSc
-
Sub-Investigator:
- Eric Williamson, PhD
-
Sub-Investigator:
- Yikai Liu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 8-16 years
- Children: >-1 y age from peak height velocity* (aPHV)
- Adolescents: -0.5 to 1.5 aPHV
- An age and sex-specific minimum of 75th percentile Beep Test level
- Considered healthy based on responses to the PAR-Q+ and a medical history form *NOTE: age from peak height velocity (aPHV): sitting/standing height
Exclusion Criteria:
- Almond or soy allergy
- Lactose intolerance
- If enrolled as a child participant: biological age outside of >-1 years from aPHV
- If enrolled as an adolescent participant: biological age outside -0.5 to 1.5 aPHV
- Inability to perform physical activity as determined by the PAR-Q+ and iPAQ
- Inability to adhere to protocol guidelines (e.g., 2-day controlled diet)
- Diagnosed medical condition under the care of a physician (e.g., type 1 diabetes)
- Consuming any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories)
- Failure to complete all four metabolic trials within four months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Children
Participants will undergo four metabolic trials in a randomized crossover design, where they will be provided with an isoenergetic (i.e., equal calories) amount of one of the following beverages upon completing a standardized bout of variably intensity exercise: 2% milk, almond 'milk,' soy 'milk,' or rice 'milk.'
|
Protein provided at 0.3 g/kg fat-free mass.
All other conditions (almond, soy and rice milk alternative beverages) will be matched to the same energy content (i.e., isoenergetic).
Macronutrient content of beverage (per 100 g): Calories: 52 kcal; Fat: 2.25 g; Carbohydrates: 4.8 g; Protein: 3.3 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 24 kcal; Fat: 1.13 g; Carbohydrates: 3.1 g; Protein: 0.3 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 39 kcal; Fat: 1.70 g; Carbohydrates: 3.0 g; Protein: 2.9 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 49 kcal; Fat: 1.09 g; Carbohydrates: 9.8 g; Protein: 0.1 g.
Other Names:
|
|
Active Comparator: Adolescent females
Participants will undergo four metabolic trials in a randomized crossover design, where they will be provided with an isoenergetic (i.e., equal calories) amount of one of the following beverages upon completing a standardized bout of variably intensity exercise: 2% milk, almond 'milk,' soy 'milk,' or rice 'milk.'
|
Protein provided at 0.3 g/kg fat-free mass.
All other conditions (almond, soy and rice milk alternative beverages) will be matched to the same energy content (i.e., isoenergetic).
Macronutrient content of beverage (per 100 g): Calories: 52 kcal; Fat: 2.25 g; Carbohydrates: 4.8 g; Protein: 3.3 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 24 kcal; Fat: 1.13 g; Carbohydrates: 3.1 g; Protein: 0.3 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 39 kcal; Fat: 1.70 g; Carbohydrates: 3.0 g; Protein: 2.9 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 49 kcal; Fat: 1.09 g; Carbohydrates: 9.8 g; Protein: 0.1 g.
Other Names:
|
|
Active Comparator: Adolescent males
Participants will undergo four metabolic trials in a randomized crossover design, where they will be provided with an isoenergetic (i.e., equal calories) amount of one of the following beverages upon completing a standardized bout of variably intensity exercise: 2% milk, almond 'milk,' soy 'milk,' or rice 'milk.'
|
Protein provided at 0.3 g/kg fat-free mass.
All other conditions (almond, soy and rice milk alternative beverages) will be matched to the same energy content (i.e., isoenergetic).
Macronutrient content of beverage (per 100 g): Calories: 52 kcal; Fat: 2.25 g; Carbohydrates: 4.8 g; Protein: 3.3 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 24 kcal; Fat: 1.13 g; Carbohydrates: 3.1 g; Protein: 0.3 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 39 kcal; Fat: 1.70 g; Carbohydrates: 3.0 g; Protein: 2.9 g.
Other Names:
Matched to the same energy intake as 0.3 g/kg FFM of 2% milk.
Macronutrient content of beverage (per 100 g): Calories: 49 kcal; Fat: 1.09 g; Carbohydrates: 9.8 g; Protein: 0.1 g.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
F13CO2
Time Frame: Duration of the metabolic trial (7 hours)
|
The rate of 13CO2 excretion based upon baseline (t=30 minutes) and isotopic steady state (t=360-420 minutes) 13CO2 enrichments in the breath and resting VCO2
|
Duration of the metabolic trial (7 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whole-Body Net Protein Balance
Time Frame: Duration of the metabolic trial (7 hours)
|
Whole-Body Net Protein Balance will be calculated based upon baseline (t=30 minutes) and isotopic steady state (t=360-420 minutes) 13CO2 enrichments in the breath and 1-[13C]phenylalanine enrichments in the urine]
|
Duration of the metabolic trial (7 hours)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Nicki Pourhashemi, BSc, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 43728
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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