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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05827666
Other study ID # 43728
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date December 2023

Study information

Verified date April 2023
Source University of Toronto
Contact Daniel R Moore, PhD
Phone 4169464088
Email dr.moore@utoronto.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The growth and development of lean body mass (i.e., muscle and bone) is instrumental to health and performance across the lifespan, especially in youth, as they actively experience growth. Thus, it is important to capitalize on physical activity and nutrition (especially dietary protein), to support the accretion of lean tissues. Eating a protein-rich meal or performing physical activity can stimulate protein synthesis, and when repeated over time, lean body mass accretion. There is currently an increasing market demand for non-dairy alternatives, due to multiple reasons including environmental, ethical, or taste preferences. However, it is important to understand how different beverages may support 'growth' (anabolism) of lean tissues after exercise. Research in adults has shown that dairy milk is superior to non-dairy milk beverages for supporting post-exercise recovery and muscle protein synthesis. However, the impact of dairy and non-dairy milk alternatives on recovery from exercise is not well understood in children. By understanding the milk beverage that best supports post-exercise recovery, the investigators can determine the optimal nutritional environment to facilitate the growth of lean tissues in the body.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
2% milk beverage
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.
Almond milk alternative beverage
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.
Soy milk alternative beverage
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.
Rice milk alternative beverage
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.

Locations

Country Name City State
Canada Goldring Centre for High Performance and Sport Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto Dairy Management Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary F13CO2 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 Whole-Body Net Protein Balance 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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05052827 - Determining the Effect of Protein Quality on Post-exercise Anabolism in Active Youth N/A
Completed NCT00700804 - Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically? N/A
Completed NCT03785002 - Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians N/A