Dietary ProteinsPBSNCT05827666
The Effect of Dairy and Dairy-Free Alternative Beverages on Post-Exercise Anabolism in Active Youth
A study testing 2% milk beverage, Almond milk alternative beverage and Soy milk alternative beverage in people with Dietary Proteins and Indicator Amino Acid Oxidation, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Proteins, Indicator Amino Acid Oxidation
- What is being tested?
- 2% milk beverage, Almond milk alternative beverage and Soy milk alternative beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Hugo JW Fung, PhD (c) contact
Canada1 site, 1 recruiting
- Recruiting
Goldring Centre for High Performance and Sport
Toronto, Ontario, M5S 2C9
Daniel Moore, PhD, 4169464088, dr.moore@utoronto.ca
Nicki Pourhashemi, BSc, 6478817899, nicki.pourhashemi@mail.utoronto.ca
About this study
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.
Read the 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.
- Conditions
- Dietary Proteins, Indicator Amino Acid Oxidation
- Being tested
- 2% milk beverage, Almond milk alternative beverage, Soy milk alternative beverage, Rice milk alternative beverage
- Keywords
- Nutrition in Youth, Growth, Active youth, Protein metabolism, Lean body mass, Whole food matrix, Protein beverage, Children, Adolescent, Indicator Amino Acid Oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% milk beverageDietary supplement
Also called Natrel 2% 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.
Almond milk alternative beverageDietary supplement
Also called Silk Original Almond 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 beverageDietary supplement
Also called Silk Original Soy 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 beverageDietary supplement
Also called Rice Dream Milk 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.
| Study group | Role | What they receive |
|---|---|---|
| Children | Active comparator | 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.' Receives: Dietary Supplement: 2% milk beverage; Dietary Supplement: Almond milk alternative beverage; Dietary Supplement: Soy milk alternative beverage; Dietary Supplement: Rice milk alternative beverage |
| Adolescent females | Active comparator | 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.' Receives: Dietary Supplement: 2% milk beverage; Dietary Supplement: Almond milk alternative beverage; Dietary Supplement: Soy milk alternative beverage; Dietary Supplement: Rice milk alternative beverage |
| Adolescent males | Active comparator | 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.' Receives: Dietary Supplement: 2% milk beverage; Dietary Supplement: Almond milk alternative beverage; Dietary Supplement: Soy milk alternative beverage; Dietary Supplement: Rice milk alternative beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of the metabolic trial (7 hours)
Secondary outcomes (1)
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]
Measured: Duration of the metabolic trial (7 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Feb 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ProteinsStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Using a single-blind randomized counterbalanced crossover design, participants will complete four metabolic trials providing one of the four isoenergetic (equal calories) beverages: 2% milk (MILK), soy 'milk,' (SOY), almond 'milk,' (ALMOND), or rice 'milk' (RICE) following a bout of variable-intensity exercise. The caloric content of the beverages is based on 0.3 g/kg FFM 2% milk.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Nicki Pourhashemi, BSc, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827666
- Sponsor's protocol ID
- 43728
- Acronym
- PBS
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy and Dairy-Free Alternative Beverages on Post-Exercise Anabolism in Active Youth
- ClinicalTrials.gov ID
- NCT05827666
- Acronym / sponsor ID
- PBS / 43728
- Conditions
- Dietary Proteins, Indicator Amino Acid Oxidation
- Keywords
- Nutrition in Youth, Growth, Active youth, Protein metabolism, Lean body mass, Whole food matrix, Protein beverage, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Using a single-blind randomized counterbalanced crossover design, participants will complete four metabolic trials providing one of the four isoenergetic (equal calories) beverages: 2% milk (MILK), soy 'milk,' (SOY), almond 'milk,' (ALMOND), or rice 'milk' (RICE) following a bout of variable-intensity exercise. The caloric content of the beverages is based on 0.3 g/kg FFM 2% milk.
| Arm | Type | Receives |
|---|---|---|
| Children | Active comparator | Dietary Supplement: 2% milk beverage, Dietary Supplement: Almond milk alternative beverage, Dietary Supplement: Soy milk alternative beverage, Dietary Supplement: Rice milk alternative beverageParticipants 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.' |
| Adolescent females | Active comparator | Dietary Supplement: 2% milk beverage, Dietary Supplement: Almond milk alternative beverage, Dietary Supplement: Soy milk alternative beverage, Dietary Supplement: Rice milk alternative beverageParticipants 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.' |
| Adolescent males | Active comparator | Dietary Supplement: 2% milk beverage, Dietary Supplement: Almond milk alternative beverage, Dietary Supplement: Soy milk alternative beverage, Dietary Supplement: Rice milk alternative beverageParticipants 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.' |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% milk beverageAlso: Natrel 2% milkProtein 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. | Dietary supplement | Adolescent females, Adolescent males, Children |
| Almond milk alternative beverageAlso: Silk Original Almond BeverageMatched 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. | Dietary supplement | Adolescent females, Adolescent males, Children |
| Soy milk alternative beverageAlso: Silk Original Soy BeverageMatched 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. | Dietary supplement | Adolescent females, Adolescent males, Children |
| Rice milk alternative beverageAlso: Rice Dream Milk BeverageMatched 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. | Dietary supplement | Adolescent females, Adolescent males, Children |
Primary outcome
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
1 secondary outcome
Whole-Body Net Protein Balance
Time frame: Duration of the metabolic trial (7 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo JW Fung, PhD (c) contact
Nicki Pourhashemi, BSc study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% milk beverage, Almond milk alternative beverage and Soy milk alternative beverage in people with Dietary Proteins and Indicator Amino Acid Oxidation, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel R Moore, PhD (4169464088, dr.moore@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F13CO2 (time frame: Duration of the metabolic trial (7 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.