ObesityNCT04284683
Physical Activity, Meal Composition, and RMR Among Children Adolescent and Adults
A study testing DRINK - Water, Protein, Fat, Carbohydrate in people with Obesity, run by Meir Medical Center at 2 sites in Israel.
Trial summary
Resting metabolic rate (RMR) is the amount of energy the body uses at rest, and accounts for 60%-70% of daily energy expenditure. Although measured at rest, RMR is strongly influenced by physical activity because the increased metabolic rate during exercise is partially carried over even when exercise stops. Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- DRINK - Water, Protein, Fat, Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Mar 2019to 29 Sep 2020
- 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 6 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 6-30 years.
- Normal weight and over weight participants
Who cannot join
- Elite athletes
- Participants with physical limitations concerning strenuous physical activity.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
'Meir children's sport and health center'
Kfar Saba, 44281
Meir Medical Center
Kfar Saba, 44281
About this study
Resting metabolic rate (RMR) is the amount of energy the body uses at rest, and accounts for 60%-70% of daily energy expenditure. Although measured at rest, RMR is strongly influenced by physical activity because the increased metabolic rate during exercise is partially carried over even when exercise stops. Therefore, persons who are physically active maintain higher RMR and less body fat than do sedentary controls. It is well known that high energy intake stimulates whereas caloric restriction reduces RMR. Food thermogenesis corresponds to approximately 10% of daily energy expenditure. Diet-induced thermogenesis is greater on a high protein and carbohydrate diet than on a fat diet. Other factors the affect RMR are age (RMR tends to decline progressively over the life span) and body composition (lean body mass is regarded as the main determinant of RMR). However, the research regarding the effect of a specific combination of macronutrients and exercise on RMR is scarce.
Therefore, the aim of the current study is to assess the combined effect of a meal composition and physical activity on RMR in normal weight and overweight children, adolescents and adults.
Read the detailed description
One hundred (100) healthy volunteers, 50 normal weight (NW) and 50 overweight (OW), age 6-30 will be recruited for the current study. All participants and/or their parents will sign informed consent prior to their participation. Participants will visit the clinic 4 times, with a week's difference between them. Participants will arrive at the clinic after 12 hours of fasting and avoiding physical activity for 14 hours. During the first visit, their RMR will be measured, and 15min later they will perform 60 min of aerobic training, and 15 minutes later they will be asked to drink 300ml of water, followed by a second RMR test. In the consecutive visits they will follow the same routine without the first RMR test, and drink either carbohydrate enriched shake, protein enriched shake or fat enriched shake; in a random order.
- Conditions
- Obesity
- Being tested
- DRINK - Water, Protein, Fat, Carbohydrate
- Keywords
- RMR, Macro nutrients, Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRINK - Water, Protein, Fat, CarbohydrateOther
Following exercise participants will consume a drink (with different composition in each visit) and than RMR will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Normal and overweight participants | Experimental | Healthy males and female, age 6 to 30. BMI range for participants age 6 to 18 is between 5th percentile to 85th percentile, overweight BMI between the 85 and 95th percentile, and obese, above the 95th percentile.
BMI range for participants age 18 to 30 is between 18.5 to 24.9 for normal weight, 25-30 for overweight and above 30 for obese. Receives: Other: DRINK - Water, Protein, Fat, Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RMR from baseline
Resting Metabolic Rate
Measured: Through study completion, an average of 6 weeks (during 4 visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Mar 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Nemet, MD, Meir Medical Center
- Investigators
- Dan Nemet, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284683
- Sponsor's protocol ID
- MeirMc0173-18CTIL
- Status last verified
- Sep 2020
- First submitted
- 17 Mar 2019
- Last updated
- 30 Sep 2020
- 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 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Meal Composition, and RMR Among Children Adolescent and Adults
- ClinicalTrials.gov ID
- NCT04284683
- Acronym / sponsor ID
- MeirMc0173-18CTIL
- Conditions
- Obesity
- Keywords
- RMR, Macro nutrients, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 26 Feb 2020 (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.
Resting metabolic rate (RMR) is the amount of energy the body uses at rest, and accounts for 60%-70% of daily energy expenditure. Although measured at rest, RMR is strongly influenced by physical activity because the increased metabolic rate during exercise is partially carried over even when exercise stops. Therefore, persons who are physically active maintain higher RMR and less body fat than do sedentary controls. It is well known that high energy intake stimulates whereas caloric restriction reduces RMR. Food thermogenesis corresponds to approximately 10% of daily energy expenditure. Diet-induced thermogenesis is greater on a high protein and carbohydrate diet than on a fat diet. Other factors the affect RMR are age (RMR tends to decline progressively over the life span) and body composition (lean body mass is regarded as the main determinant of RMR). However, the research regarding the effect of a specific combination of macronutrients and exercise on RMR is scarce.
Therefore, the aim of the current study is to assess the combined effect of a meal composition and physical activity on RMR in normal weight and overweight children, adolescents and adults.
Detailed description
One hundred (100) healthy volunteers, 50 normal weight (NW) and 50 overweight (OW), age 6-30 will be recruited for the current study. All participants and/or their parents will sign informed consent prior to their participation. Participants will visit the clinic 4 times, with a week's difference between them. Participants will arrive at the clinic after 12 hours of fasting and avoiding physical activity for 14 hours. During the first visit, their RMR will be measured, and 15min later they will perform 60 min of aerobic training, and 15 minutes later they will be asked to drink 300ml of water, followed by a second RMR test. In the consecutive visits they will follow the same routine without the first RMR test, and drink either carbohydrate enriched shake, protein enriched shake or fat enriched shake; in a random order.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal and overweight participants | Experimental | Other: DRINK - Water, Protein, Fat, CarbohydrateHealthy males and female, age 6 to 30. BMI range for participants age 6 to 18 is between 5th percentile to 85th percentile, overweight BMI between the 85 and 95th percentile, and obese, above the 95th percentile. BMI range for participants age 18 to 30 is between 18.5 to 24.9 for normal weight, 25-30 for overweight and above 30 for obese. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 6-30 years.
- Normal weight and over weight participants
Key exclusion criteria (2 listed)
- Elite athletes
- Participants with physical limitations concerning strenuous physical activity.
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 |
|---|---|---|
| DRINK - Water, Protein, Fat, CarbohydrateFollowing exercise participants will consume a drink (with different composition in each visit) and than RMR will be evaluated. | Other | Normal and overweight participants |
Primary outcome
Change in RMR from baseline
Time frame: Through study completion, an average of 6 weeks (during 4 visits)
Resting Metabolic Rate
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 30 Sep 2020.
- 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.
Dan Nemet, MD principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DRINK - Water, Protein, Fat, Carbohydrate in people with Obesity, run by Meir Medical Center at 2 sites in Israel.
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 2 inclusion and 2 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 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
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?
Change in RMR from baseline (time frame: Through study completion, an average of 6 weeks (during 4 visits)). 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 30 Sep 2020.