ObesityNCT01551238
Energy Expenditure, Sleep and Macronutrients
A study testing Differences in protein content of meals in people with Obesity and Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Overnutrition
- What is being tested?
- Differences in protein content of meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Dec 2013
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- age between 18-35 years
- BMI 18-27 kg/m2
- non-smoking
- weight stable (weight change < 3 kg during the last 6 months)
- no sleeping problems
- not using a more than moderate amount of alcohol (> 10 consumptions/wk)
- not using medication or supplements except for oral contraceptives in women
Who cannot join
- not healthy
- do not meet the criteria for BMI and age
- smoking
- not being weight stable
- using medication or supplements except for oral contraceptives in women
- sleeping problems
Show all 9Show fewer
- using a more than moderate alcohol consumption
- pregnant or lactating
- allergic for the used food items
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
Maastricht, 6200 MD
Hanne K. Gonnissen, Msc., +31433884596, hkj.gonnissen@maastrichtuniversity.nl
Eveline A. Martens, Msc., +31433884596, eap.martens@maastrichtuniversity.nl
About this study
Official title: Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio
The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.
Read the detailed description
The prevalence of obesity has increased worldwide to epidemic proportions. For long-term treatment success permanent lifestyle changes are necessary with regard to approach to food, physical activity patterns and behavior to emotional stress. Moreover, an association has been shown between sleep disturbance and obesity. Weight loss strategies regarding food intake regulation mainly focused on changing patterns of fat and carbohydrate consumption during the last decades. The role of protein has largely been ignored. However, protein has been observed to increase satiety and energy expenditure to a greater extent than carbohydrate and fat and can therefore reduce energy intake. However, it still has to be confirmed if this effect is permanent or transient over a longer period of time. Moreover, dietary intakes may significantly affect sleep when macronutrient intakes are manipulated. Since sleep deprivation has been recognized as a risk factor for obesity, improving sleep by a change in macronutrient intake would be promising in the treatment of obesity.
- Conditions
- Obesity, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Signs and Symptoms
- Being tested
- Differences in protein content of meals
- Keywords
- Energy expenditure, Sleep, Protein, Carbohydrate
- Medical subject headings
- Obesity, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differences in protein content of mealsDietary supplement
Differences in protein content (energy percent) of meals
Differences in protein content of mealsDietary supplement
Differences in protein content (energy percent) of meals
| Study group | Role | What they receive |
|---|---|---|
| Protein intake of 5 energy percent | Experimental | Not described Receives: Dietary Supplement: Differences in protein content of meals |
| Protein intake of 30 energy percent | Experimental | Not described Receives: Dietary Supplement: Differences in protein content of meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure
Measured: 48 hours
substrate oxidation
Measured: 48 hours
sleep
Measured: 48 hours
Secondary outcomes (2)
body composition
Measured: 48 hours
fat distribution
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margriet S. Westerterp-Plantenga, Prof. dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551238
- Sponsor's protocol ID
- NL39152
- Status last verified
- May 2013
- First submitted
- 14 Dec 2011
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hursel R, Martens EA, Gonnissen HK, Hamer HM, Senden JM, van Loon LJ, Westerterp-Plantenga MS. Prolonged Adaptation to a Low or High Protein Diet Does Not Modulate Basal Muscle Protein Synthesis Rates - A Substudy. PLoS One. 2015 Sep 14;10(9):e0137183. doi: 10.1371/journal.pone.0137183. eCollection 2015.
PubMed 26367529Martens EA, Gonnissen HK, Gatta-Cherifi B, Janssens PL, Westerterp-Plantenga MS. Maintenance of energy expenditure on high-protein vs. high-carbohydrate diets at a constant body weight may prevent a positive energy balance. Clin Nutr. 2015 Oct;34(5):968-75. doi: 10.1016/j.clnu.2014.10.007. Epub 2014 Nov 8.
PubMed 25466951Martens EA, Gatta-Cherifi B, Gonnissen HK, Westerterp-Plantenga MS. The potential of a high protein-low carbohydrate diet to preserve intrahepatic triglyceride content in healthy humans. PLoS One. 2014 Oct 16;9(10):e109617. doi: 10.1371/journal.pone.0109617. eCollection 2014.
PubMed 25330327
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure and Sleep in Response to Protein/Carbohydrate and Fat Ratio
- ClinicalTrials.gov ID
- NCT01551238
- Acronym / sponsor ID
- NL39152
- Conditions
- Obesity, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Signs and Symptoms
- Keywords
- Energy expenditure, Sleep, Protein, Carbohydrate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Mar 2012 (estimated)
- 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 purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.
Detailed description
The prevalence of obesity has increased worldwide to epidemic proportions. For long-term treatment success permanent lifestyle changes are necessary with regard to approach to food, physical activity patterns and behavior to emotional stress. Moreover, an association has been shown between sleep disturbance and obesity. Weight loss strategies regarding food intake regulation mainly focused on changing patterns of fat and carbohydrate consumption during the last decades. The role of protein has largely been ignored. However, protein has been observed to increase satiety and energy expenditure to a greater extent than carbohydrate and fat and can therefore reduce energy intake. However, it still has to be confirmed if this effect is permanent or transient over a longer period of time. Moreover, dietary intakes may significantly affect sleep when macronutrient intakes are manipulated. Since sleep deprivation has been recognized as a risk factor for obesity, improving sleep by a change in macronutrient intake would be promising in the treatment of obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein intake of 5 energy percent | Experimental | Dietary Supplement: Differences in protein content of meals |
| Protein intake of 30 energy percent | Experimental | Dietary Supplement: Differences in protein content of meals |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- healthy
- age between 18-35 years
- BMI 18-27 kg/m2
- non-smoking
- weight stable (weight change < 3 kg during the last 6 months)
Key exclusion criteria (9 listed)
- not healthy
- do not meet the criteria for BMI and age
- smoking
- not being weight stable
- using medication or supplements except for oral contraceptives in women
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 |
|---|---|---|
| Differences in protein content of mealsDifferences in protein content (energy percent) of meals | Dietary supplement | Protein intake of 5 energy percent |
| Differences in protein content of mealsDifferences in protein content (energy percent) of meals | Dietary supplement | Protein intake of 30 energy percent |
Primary outcome
energy expenditure
Time frame: 48 hours
substrate oxidation
Time frame: 48 hours
sleep
Time frame: 48 hours
2 secondary outcomes
body composition
Time frame: 48 hours
fat distribution
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Derived from this study: PubMed 26367529Hursel R, Martens EA, Gonnissen HK, Hamer HM, Senden JM, van Loon LJ, Westerterp-Plantenga MS. Prolonged Adaptation to a Low or High Protein Diet Does Not Modulate Basal Muscle Protein Synthesis Rates - A Substudy. PLoS One. 2015 Sep 14;10(9):e0137183. doi: 10.1371/journal.pone.0137183. eCollection 2015.
- Derived from this study: PubMed 25466951Martens EA, Gonnissen HK, Gatta-Cherifi B, Janssens PL, Westerterp-Plantenga MS. Maintenance of energy expenditure on high-protein vs. high-carbohydrate diets at a constant body weight may prevent a positive energy balance. Clin Nutr. 2015 Oct;34(5):968-75. doi: 10.1016/j.clnu.2014.10.007. Epub 2014 Nov 8.
- Derived from this study: PubMed 25330327Martens EA, Gatta-Cherifi B, Gonnissen HK, Westerterp-Plantenga MS. The potential of a high protein-low carbohydrate diet to preserve intrahepatic triglyceride content in healthy humans. PLoS One. 2014 Oct 16;9(10):e109617. doi: 10.1371/journal.pone.0109617. eCollection 2014.
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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.
Margriet S. Westerterp-Plantenga, Prof. dr. principal investigator
Maastricht 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 Differences in protein content of meals in people with Obesity and Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
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 8 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 3 May 2013. 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 Netherlands. 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 Hanne K. Gonnissen, Msc. (+31433884596, hkj.gonnissen@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy expenditure (time frame: 48 hours). The study lists 3 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 NCT01551238, which also lists 3 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 3 May 2013.