Inflammatory ResponseNCT03947801
Dairy Consumption During a High-intensity, High-volume Training Week in Young Athletes
A study testing Greek Yogurt and Isoenergetic carbohydrate in people with Inflammatory Response and Sports Performance, run by Brock University at 1 site in Canada.
Trial summary
Our proposed study is a 5-d double-blind randomised cross-over trial, seeking to simulate a training identification camp in competitive adolescent soccer players The purpose of the proposed study is to investigate whether increased protein consumption by Greek yogurt, compared to an isoenergetic carbohydrate (CHO)… Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Sports Performance
- What is being tested?
- Greek Yogurt and Isoenergetic carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 23 Nov 2019
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant are female within the desired age ranges (11-16y)
- Participants are competitive soccer players
- Previous participation in high-performance training environment (periodization)
Who cannot join
- Participant is not female or falls outside of the desired age ranges (11-16y)
- Chronic/frequent use of medications that could affect inflammatory function - NSAIDS or Corticosteroids.
- Musculoskeletal injury - resulting in the inability to train and/or perform the baseline/post testing.
Trial locations and contacts
1 site in 1 country.
About this study
Our proposed study is a 5-d double-blind randomised cross-over trial, seeking to simulate a training identification camp in competitive adolescent soccer players
The purpose of the proposed study is to investigate whether increased protein consumption by Greek yogurt, compared to an isoenergetic carbohydrate (CHO) control supplement, consumed immediately following exercise training, prior to sleep and between breakfast and lunch, for a week during an intense training period (high volume, high intensity) will:
Read more
- Attenuate the pro-inflammatory response (cytokines, acute phase proteins)
- Reduced the severity of muscle damage and impairment (creatine kinase)
- Maintain performance
Secondary outcome measures:
- Increase bone turnover (in favour of formation)
Read the detailed description
The proposed study is a randomized, double-blinded, cross-over trial. The protocol will consist of an information session, two identical training camps consisting of 5 consecutive days of intensified soccer training, differing only by nutritional intervention, and identical pre-and post-training session testing. Each testing block will be separated by 28-d to allow for an adequate wash-out and recovery period, during which participants would resume their regular soccer activities
Study Procedures:
All tests and measurements will be performed within eight-weeks. Specifically, participants will attend 1 information session, two identical pre- and post- training/testing sessions and two identical soccer specific training camps.
Information session:
One week prior to the initial soccer specific training camp, participants will be informed of all tests and procedures that will take place and be familiarized with all testing protocols.
Pre- and Post-training testing:
All participants will be tested twice: on the day before (pre) and day following (post) the 5-d soccer specific training camp. Specifically, Participants, will arrive at the University for pre- and post-training testing in the morning at the same time. Body composition measurements will be performed (e.g., standing/seated height, mass, % body fat) followed by fasted venous blood and saliva sampling. A standardized breakfast would then be provided followed by an adequate rest and digest period before performance testing (~1.5h). Performance testing would include a battery of soccer specific tests that cover, power (counter-movement jump, broad jump), speed (10m and 20m sprint), agility (modified 5-0-5) and aerobic capacity (beep-test). During both pre-and-post-testing sessions participants would consume the same standardised breakfast and perform the same tests in the same order for consistency amongst trials which would be repeated between the two testing blocks.
Soccer training:
The simulated 5-d soccer-specific training will be structured to mimic a heavy-volume, high-intensity training camp. Training sessions would occur at the same time each day in the evening for consistency. Drills/exercises will be administered by a certified technical soccer coach and knowledgeable training staff. Each session will began with a 15 min dynamic warm-up followed by 90 min of soccer-specific training, ending with a 15 min cool-down. The 90 min of soccer-specific training will be performed at maximal effort and consist of agility, sprinting and plyometric exercises as well as ball-handling, small-sided games (rondo) and shooting. Following each training session rating of perceived exertion (RPE) will be measured as an indicator of internal load.
Food/Drink supplement consumption:
During the study, three servings of 160 g of 0% plain GY (~115 kcals, 17 g protein, ~11.5 g carbs, 0 fat), or 30 g of isoenergetic CHO (~115 kcal, 0.04 g protein, ~28.6 g carbs, 0 fat) will be provided to participants immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. The yogurt will be sweetened or flavored with a non-caloric vanilla flavouring to match the taste of the control supplement. The CHO control supplement group will be an isoenergetic dose of a maltodextrin-based semi-solid pudding. This product will be made from non-fat vanilla pudding powder (1 part), maltodextrin (4 parts) and water. This product has been designed to resemble the consistency and texture of Greek yogurt.
Measurements
Questionnaires: Participant Screening and Medical History, Training History, Food frequency Questionnaire (FFQ), sessional RPE.
Anthropometric and body composition measurements: height, seated height, body mass and body fat percentage (%) using bioelectrical impedance analysis (BIA, InBody520; Biospace Co., Ltd., Seoul, S. Korea).
Somatic maturity: maturity offset (years from the age of peak height velocity) will be calculated based on height, seated height and weight measurements.
Exercise performance: will be examined prior to, as well as following each training intervention week. These tests are common in soccer and athletes are familiar with them. To limit confounding exercise influence on both biochemical and performance parameters, participants will be asked to refrain from other activities outside those prescribed to them during the training sessions and 48h prior to the initial pre-assessment visit.
Venous blood and saliva samples: will be collected on 4 separate occasions (24h prior and 24h following the last training session of each training intervention week). To control for circadian rhythm, the exercise session and related blood and saliva samples will be conducted at the same time of day. Saliva samples will be used to examine endocrine response. Venous blood samples will be used to examine inflammatory markers (cytokines - IL-6, IL-10 and TNF-α), c-reactive protein (CRP), IGF-I and indicators of muscle fatigue/damage (CK). Secondary measures may include irisin, oxidative stress (TBARS and ROS) and bone turnover by examining circulating markers of bone formation (PINP, Osteocalcin, BAP, OPG) and of bone resorption (CTX, TRAP, RANKL).
- Conditions
- Inflammatory Response, Sports Performance
- Being tested
- Greek Yogurt, Isoenergetic carbohydrate
- Keywords
- Greek Yogurt, Adolescent Athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greek YogurtOther
Female competitive soccer players (11-16y) will consume 0% plain Greek yogurt immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.
Isoenergetic carbohydrateOther
Female competitive soccer players (11-16y) will consume an isoenergetic carbohydrate supplement immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.
| Study group | Role | What they receive |
|---|---|---|
| Greek Yogurt condition | Experimental | 3x 160g of 0% Plain Greek yogurt (~115 kcals, 17 g protein, ~11.5 g carbs, 0 fat) consumed immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. Receives: Other: Greek Yogurt |
| Isoenergetic condition - Carbohydrate | Placebo comparator | 3x 30g of isoenergetic CHO supplement (~115 kcal, 0.04 g protein, ~28.6 g carbs, 0 fat) consumed immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. Receives: Other: Isoenergetic carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass (kg)
Anthropometric measures
Measured: 8 weeks
Height (cm)
Anthropometric measures
Measured: 8 weeks
Seated height (cm)
Used to calculate maturity offset in years from peak height velocity
Measured: 8 weeks
Body fat (%)
Body composition
Measured: 8 weeks
Rate of perceived exertion
1-10 scale of perceived exertion
Measured: 8 weeks
Serum concentrations of BAP (ng/ml)
Bone formation marker
Measured: 8 weeks
Serum concentrations of PINP (ng/ml)
Bone formation marker
Measured: 8 weeks
Serum concentrations of OPG (pg/ml)
Bone formation marker
Measured: 8 weeks
Serum concentrations of CTX (ng/ml)
Bone resorption marker
Measured: 8 weeks
Serum concentrations of TRAP (ng/ml)
Bone resorption marker
Measured: 8 weeks
Serum concentrations of RANKL (pg/ml)
Bone resorption marker
Measured: 8 weeks
Plasma concentrations of irisin (ng/ml)
Plasma concentrations of pro-and-anti-inflammatory cytokines
Measured: 8 weeks
Plasma concentrations of IL-6 (pg/ml)
Plasma concentrations of pro-and-anti-inflammatory cytokines
Measured: 8 weeks
Plasma concentrations of IL-10 (pg/ml)
Plasma concentrations of pro-and-anti-inflammatory cytokines
Measured: 8 weeks
Plasma concentrations of TNF-alpha (pg/ml)
Plasma concentrations of pro-and-anti-inflammatory cytokines
Measured: 8 weeks
Plasma concentrations of CRP (pg/ml)
Plasma concentrations of pro-and-anti-inflammatory cytokines
Measured: 8 weeks
Plasma concentration of creatine kinase (U/L)
Muscle damage
Measured: 8 weeks
Secondary outcomes (6)
Serum concentration of IGF-1 (pg/ml)
Serum concentration of IGF-1
Measured: 8 weeks
Plasma concentration of TBARS
Oxidative stress
Measured: 8 weeks
Plasma concentration of ROS
Oxidative stress
Measured: 8 weeks
Saliva concentrations of cortisol (ug/dl)
Endocrine response
Measured: 8 weeks
Saliva concentrations of testosterone (pg/ml)
Endocrine response
Measured: 8 weeks
Oxidative stress
Plasma concentrations of markers of oxidative stress
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Jul 2019
- Primary completion23 Nov 2019
- Study completion23 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PKlentrou, Brock University
- Investigators
- Panagiota Klentrou, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947801
- Sponsor's protocol ID
- 18-289-Klentrou
- Status last verified
- May 2022
- First submitted
- 8 May 2019
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKinlay BJ, Wallace PJ, Olansky S, Woods S, Kurgan N, Roy BD, Josse AR, Falk B, Klentrou P. Intensified training in adolescent female athletes: a crossover study of Greek yogurt effects on indices of recovery. J Int Soc Sports Nutr. 2022 Mar 22;19(1):17-33. doi: 10.1080/15502783.2022.2044732. eCollection 2022.
PubMed 35599913Klentrou P, McKee K, McKinlay BJ, Kurgan N, Roy BD, Falk B. Circulating Levels of Bone Markers after Short-Term Intense Training with Increased Dairy Consumption in Adolescent Female Athletes. Children (Basel). 2021 Oct 25;8(11):961. doi: 10.3390/children8110961.
PubMed 34828674
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Consumption During a High-intensity, High-volume Training Week in Young Athletes
- ClinicalTrials.gov ID
- NCT03947801
- Acronym / sponsor ID
- 18-289-Klentrou
- Conditions
- Inflammatory Response, Sports Performance
- Keywords
- Greek Yogurt, Adolescent Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 23 Nov 2019 (actual)
- Study completion
- 23 Nov 2019 (actual)
- First posted
- 13 May 2019 (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.
Our proposed study is a 5-d double-blind randomised cross-over trial, seeking to simulate a training identification camp in competitive adolescent soccer players
The purpose of the proposed study is to investigate whether increased protein consumption by Greek yogurt, compared to an isoenergetic carbohydrate (CHO) control supplement, consumed immediately following exercise training, prior to sleep and between breakfast and lunch, for a week during an intense training period (high volume, high intensity) will:
- Attenuate the pro-inflammatory response (cytokines, acute phase proteins)
- Reduced the severity of muscle damage and impairment (creatine kinase)
- Maintain performance
Secondary outcome measures:
- Increase bone turnover (in favour of formation)
Detailed description
The proposed study is a randomized, double-blinded, cross-over trial. The protocol will consist of an information session, two identical training camps consisting of 5 consecutive days of intensified soccer training, differing only by nutritional intervention, and identical pre-and post-training session testing. Each testing block will be separated by 28-d to allow for an adequate wash-out and recovery period, during which participants would resume their regular soccer activities
Study Procedures:
All tests and measurements will be performed within eight-weeks. Specifically, participants will attend 1 information session, two identical pre- and post- training/testing sessions and two identical soccer specific training camps.
Information session:
One week prior to the initial soccer specific training camp, participants will be informed of all tests and procedures that will take place and be familiarized with all testing protocols.
Pre- and Post-training testing:
All participants will be tested twice: on the day before (pre) and day following (post) the 5-d soccer specific training camp. Specifically, Participants, will arrive at the University for pre- and post-training testing in the morning at the same time. Body composition measurements will be performed (e.g., standing/seated height, mass, % body fat) followed by fasted venous blood and saliva sampling. A standardized breakfast would then be provided followed by an adequate rest and digest period before performance testing (~1.5h). Performance testing would include a battery of soccer specific tests that cover, power (counter-movement jump, broad jump), speed (10m and 20m sprint), agility (modified 5-0-5) and aerobic capacity (beep-test). During both pre-and-post-testing sessions participants would consume the same standardised breakfast and perform the same tests in the same order for consistency amongst trials which would be repeated between the two testing blocks.
Soccer training:
The simulated 5-d soccer-specific training will be structured to mimic a heavy-volume, high-intensity training camp. Training sessions would occur at the same time each day in the evening for consistency. Drills/exercises will be administered by a certified technical soccer coach and knowledgeable training staff. Each session will began with a 15 min dynamic warm-up followed by 90 min of soccer-specific training, ending with a 15 min cool-down. The 90 min of soccer-specific training will be performed at maximal effort and consist of agility, sprinting and plyometric exercises as well as ball-handling, small-sided games (rondo) and shooting. Following each training session rating of perceived exertion (RPE) will be measured as an indicator of internal load.
Food/Drink supplement consumption:
During the study, three servings of 160 g of 0% plain GY (~115 kcals, 17 g protein, ~11.5 g carbs, 0 fat), or 30 g of isoenergetic CHO (~115 kcal, 0.04 g protein, ~28.6 g carbs, 0 fat) will be provided to participants immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. The yogurt will be sweetened or flavored with a non-caloric vanilla flavouring to match the taste of the control supplement. The CHO control supplement group will be an isoenergetic dose of a maltodextrin-based semi-solid pudding. This product will be made from non-fat vanilla pudding powder (1 part), maltodextrin (4 parts) and water. This product has been designed to resemble the consistency and texture of Greek yogurt.
Measurements
Questionnaires: Participant Screening and Medical History, Training History, Food frequency Questionnaire (FFQ), sessional RPE.
Anthropometric and body composition measurements: height, seated height, body mass and body fat percentage (%) using bioelectrical impedance analysis (BIA, InBody520; Biospace Co., Ltd., Seoul, S. Korea).
Somatic maturity: maturity offset (years from the age of peak height velocity) will be calculated based on height, seated height and weight measurements.
Exercise performance: will be examined prior to, as well as following each training intervention week. These tests are common in soccer and athletes are familiar with them. To limit confounding exercise influence on both biochemical and performance parameters, participants will be asked to refrain from other activities outside those prescribed to them during the training sessions and 48h prior to the initial pre-assessment visit.
Venous blood and saliva samples: will be collected on 4 separate occasions (24h prior and 24h following the last training session of each training intervention week). To control for circadian rhythm, the exercise session and related blood and saliva samples will be conducted at the same time of day. Saliva samples will be used to examine endocrine response. Venous blood samples will be used to examine inflammatory markers (cytokines - IL-6, IL-10 and TNF-α), c-reactive protein (CRP), IGF-I and indicators of muscle fatigue/damage (CK). Secondary measures may include irisin, oxidative stress (TBARS and ROS) and bone turnover by examining circulating markers of bone formation (PINP, Osteocalcin, BAP, OPG) and of bone resorption (CTX, TRAP, RANKL).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greek Yogurt condition | Experimental | Other: Greek Yogurt3x 160g of 0% Plain Greek yogurt (~115 kcals, 17 g protein, ~11.5 g carbs, 0 fat) consumed immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. |
| Isoenergetic condition - Carbohydrate | Placebo comparator | Other: Isoenergetic carbohydrate3x 30g of isoenergetic CHO supplement (~115 kcal, 0.04 g protein, ~28.6 g carbs, 0 fat) consumed immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participant are female within the desired age ranges (11-16y)
- Participants are competitive soccer players
- Previous participation in high-performance training environment (periodization)
Key exclusion criteria (3 listed)
- Participant is not female or falls outside of the desired age ranges (11-16y)
- Chronic/frequent use of medications that could affect inflammatory function - NSAIDS or Corticosteroids.
- Musculoskeletal injury - resulting in the inability to train and/or perform the baseline/post testing.
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 |
|---|---|---|
| Greek YogurtFemale competitive soccer players (11-16y) will consume 0% plain Greek yogurt immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. | Other | Greek Yogurt condition |
| Isoenergetic carbohydrateFemale competitive soccer players (11-16y) will consume an isoenergetic carbohydrate supplement immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day. | Other | Isoenergetic condition - Carbohydrate |
Primary outcome
Body mass (kg)
Time frame: 8 weeks
Anthropometric measures
Height (cm)
Time frame: 8 weeks
Anthropometric measures
Seated height (cm)
Time frame: 8 weeks
Used to calculate maturity offset in years from peak height velocity
Body fat (%)
Time frame: 8 weeks
Body composition
Rate of perceived exertion
Time frame: 8 weeks
1-10 scale of perceived exertion
Serum concentrations of BAP (ng/ml)
Time frame: 8 weeks
Bone formation marker
Serum concentrations of PINP (ng/ml)
Time frame: 8 weeks
Bone formation marker
Serum concentrations of OPG (pg/ml)
Time frame: 8 weeks
Bone formation marker
Serum concentrations of CTX (ng/ml)
Time frame: 8 weeks
Bone resorption marker
Serum concentrations of TRAP (ng/ml)
Time frame: 8 weeks
Bone resorption marker
Serum concentrations of RANKL (pg/ml)
Time frame: 8 weeks
Bone resorption marker
Plasma concentrations of irisin (ng/ml)
Time frame: 8 weeks
Plasma concentrations of pro-and-anti-inflammatory cytokines
Plasma concentrations of IL-6 (pg/ml)
Time frame: 8 weeks
Plasma concentrations of pro-and-anti-inflammatory cytokines
Plasma concentrations of IL-10 (pg/ml)
Time frame: 8 weeks
Plasma concentrations of pro-and-anti-inflammatory cytokines
Plasma concentrations of TNF-alpha (pg/ml)
Time frame: 8 weeks
Plasma concentrations of pro-and-anti-inflammatory cytokines
Plasma concentrations of CRP (pg/ml)
Time frame: 8 weeks
Plasma concentrations of pro-and-anti-inflammatory cytokines
Plasma concentration of creatine kinase (U/L)
Time frame: 8 weeks
Muscle damage
6 secondary outcomes
Serum concentration of IGF-1 (pg/ml)
Time frame: 8 weeks
Plasma concentration of TBARS
Time frame: 8 weeks
Plasma concentration of ROS
Time frame: 8 weeks
Saliva concentrations of cortisol (ug/dl)
Time frame: 8 weeks
Saliva concentrations of testosterone (pg/ml)
Time frame: 8 weeks
Oxidative stress
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Results publication: PubMed 35599913McKinlay BJ, Wallace PJ, Olansky S, Woods S, Kurgan N, Roy BD, Josse AR, Falk B, Klentrou P. Intensified training in adolescent female athletes: a crossover study of Greek yogurt effects on indices of recovery. J Int Soc Sports Nutr. 2022 Mar 22;19(1):17-33. doi: 10.1080/15502783.2022.2044732. eCollection 2022.
- Results publication: PubMed 34828674Klentrou P, McKee K, McKinlay BJ, Kurgan N, Roy BD, Falk B. Circulating Levels of Bone Markers after Short-Term Intense Training with Increased Dairy Consumption in Adolescent Female Athletes. Children (Basel). 2021 Oct 25;8(11):961. doi: 10.3390/children8110961.
- 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.
Panagiota Klentrou, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greek Yogurt and Isoenergetic carbohydrate in people with Inflammatory Response and Sports Performance, run by Brock University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass (kg) (time frame: 8 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03947801, which also lists 2 linked publications.
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 2 Jun 2022.