ObesityFruMilkNCT02168218
Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet
A study testing 7-day overfeeding in people with Obesity, run by University of Lausanne at 1 site in Switzerland.
Trial summary
This study aims at assessing the hypothesis that dietary protein content is a major factor regulating lean body mass gain and energy expenditure during overfeeding, and thus long term body weight gain To test this hypothesis, healthy normal weight male and female subjects will before and after a 7-day hypercaloric… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 7-day overfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2013to May 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good apparent health
- low physical activity
- non-smokers
Who cannot join
- vegans or following any special diet
- consumption of > 3 dl/day sweetened beverages
- changes in body > +/- 3Kg over the past 3 months
- contra-indications to magnetic resonance spectroscopy
- drug or substance abuse
- consumption > 10g/day alcohol
- lactose intolerance
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CHUV-clinical research center
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: Effects of Milk Proteins on Whole Body Protein Synthesis and Ectopic Lipid Deposition During Sucrose Overfeeding in Healthy Male Subjects
This study aims at assessing the hypothesis that dietary protein content is a major factor regulating lean body mass gain and energy expenditure during overfeeding, and thus long term body weight gain
To test this hypothesis, healthy normal weight male and female subjects will before and after a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5% total energy) or a high (20% total energy) protein intake. Each subject will be studied with both low- and high protein diets according to a randomized, crossover study. On each occasion the following measurements will be done in basal conditions (after 2-day isoenergetic, controled diet) and at the end of the 7-day overfeeding:
- whole-body protein turnover, oxidation and synthesis in fasting conditions and fed conditions (13C-labelled leucine)
- intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)
- Energy metabolism in fasted and fed conditions (indirect calorimetry)
- plasma concentration of glucose, non-esterified fatty acids, total triglyceride, very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and low-protein sucrose overfeeding on whole body protein synthesis will be compared using two-way ANOVA; relationships between changes in whole body protein synthesis on one hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and plasma concentration of metabolic variables on the other hand, will be evaluated by linear regression analysis
- Conditions
- Obesity
- Being tested
- 7-day overfeeding
- Keywords
- protein synthesis, intrahepatic fat, lean body mass, IGF1, energy metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day overfeedingOther
7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements
| Study group | Role | What they receive |
|---|---|---|
| high protein | Experimental | 20% protein diet Receives: Other: 7-day overfeeding |
| low protein | Active comparator | 7.5% protein diet Receives: Other: 7-day overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
whole body protein synthesis
Whole body protein synthesis, protein turnover, and protein oxidation will be calculated using 13C-labelled leucine infusion in both fasted and fed conditions
Measured: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Secondary outcomes (3)
intrahepatic and intramuscular fat concentration
Intrahepatic and intramuscular fat concentration will be measured by in-vivo 1H-Magnetic Resonance Spectroscopy
Measured: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Energy expenditure
Energy expenditure will be measured by indirect calorimetry min fasted and fed conditions
Measured: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Metabolic variables in plasma samples
Plasma glucose, insulin, nonesterified fatty acids, triglycerides, VLDL-triglycerides, insulin, glucagon GH, IGF1, IGFBP1, 2 and 3 will be measured in fasted and fed conditions
Measured: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2016
- Study completionMay 2016
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168218
- Sponsor's protocol ID
- 218/13
- Acronym
- FruMilk
- Status last verified
- May 2018
- First submitted
- 5 Jun 2014
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Milk Proteins on Whole Body Protein Synthesis and Ectopic Lipid Deposition During Sucrose Overfeeding in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02168218
- Acronym / sponsor ID
- FruMilk / 218/13
- Conditions
- Obesity
- Keywords
- protein synthesis, intrahepatic fat, lean body mass, IGF1, energy metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Dec 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Jun 2014 (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.
This study aims at assessing the hypothesis that dietary protein content is a major factor regulating lean body mass gain and energy expenditure during overfeeding, and thus long term body weight gain
To test this hypothesis, healthy normal weight male and female subjects will before and after a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5% total energy) or a high (20% total energy) protein intake. Each subject will be studied with both low- and high protein diets according to a randomized, crossover study. On each occasion the following measurements will be done in basal conditions (after 2-day isoenergetic, controled diet) and at the end of the 7-day overfeeding:
- whole-body protein turnover, oxidation and synthesis in fasting conditions and fed conditions (13C-labelled leucine)
- intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)
- Energy metabolism in fasted and fed conditions (indirect calorimetry)
- plasma concentration of glucose, non-esterified fatty acids, total triglyceride, very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and low-protein sucrose overfeeding on whole body protein synthesis will be compared using two-way ANOVA; relationships between changes in whole body protein synthesis on one hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and plasma concentration of metabolic variables on the other hand, will be evaluated by linear regression analysis
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high protein | Experimental | Other: 7-day overfeeding20% protein diet |
| low protein | Active comparator | Other: 7-day overfeeding7.5% protein diet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good apparent health
- low physical activity
- non-smokers
Key exclusion criteria (7 listed)
- vegans or following any special diet
- consumption of > 3 dl/day sweetened beverages
- changes in body > +/- 3Kg over the past 3 months
- contra-indications to magnetic resonance spectroscopy
- drug or substance abuse
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 |
|---|---|---|
| 7-day overfeeding7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements | Other | high protein, low protein |
Primary outcome
whole body protein synthesis
Time frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Whole body protein synthesis, protein turnover, and protein oxidation will be calculated using 13C-labelled leucine infusion in both fasted and fed conditions
3 secondary outcomes
intrahepatic and intramuscular fat concentration
Time frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Energy expenditure
Time frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Metabolic variables in plasma samples
Time frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
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 4 May 2018.
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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.
Luc Tappy, MD principal investigator
University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-day overfeeding in people with Obesity, run by University of Lausanne at 1 site in Switzerland.
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 7 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 4 May 2018. 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 Switzerland. 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?
whole body protein synthesis (time frame: after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet). 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 4 May 2018.