ObesityNCT01646749
Effects of Beef Protein Consumption on Energy Intake
A study testing Differences in protein content (En%) of meals in people with Obesity and Severe Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine ad libitum daily energy intake, body weight changes and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, body mass index (BMI) and fat mass and obesity-associated (FTO) gene alleles. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Severe Overweight
- What is being tested?
- Differences in protein content (En%) of meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Feb 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Age 18-70 years
- BMI 18-35 kg/m2
- Non-smoking
- Weight stable
Who cannot join
- Smoking
- Use of medication
- More than moderate alcohol consumption
- Vegetarian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Beef Protein Consumption on Energy Intake - The Protein Leverage Hypothesis
The purpose of this study is to determine ad libitum daily energy intake, body weight changes and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, body mass index (BMI) and fat mass and obesity-associated (FTO) gene alleles.
Read the detailed description
The protein leverage hypothesis requires specific evidence whether energy intake would depend on a possible protein intake target in humans. Meat protein as complete protein may show most beneficial effects on variables regarding food intake regulation.
- Conditions
- Obesity, Severe Overweight
- Being tested
- Differences in protein content (En%) of meals
- Keywords
- Energy intake, Beef protein, Satiety, Protein leverage hypothesis
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differences in protein content (En%) of mealsDietary supplement
Also called All food items will be commercial available.
The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content.
| Study group | Role | What they receive |
|---|---|---|
| Protein intake of 5 energy percent (En%) | Experimental | Not described Receives: Dietary Supplement: Differences in protein content (En%) of meals |
| Protein intake of 15 En% | Experimental | Not described Receives: Dietary Supplement: Differences in protein content (En%) of meals |
| Protein intake of 30 En% | Experimental | Not described Receives: Dietary Supplement: Differences in protein content (En%) of meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Body weight will be measured on day 1, 6 and 12. Subsequently, the change in body weight over time will be calculated.
Measured: 11 days
Appetite profile
Appetite profile will be measured by means of questionnaires: visual analogue scales (VAS). Area under the curve (AUC) will be calculated over 12 consecutive days.
Measured: 12 consecutive days
Energy intake
Total energy intake over 12 days will be determined for each subject by adding energy intake during meals to energy intake from snack consumption.
Measured: 12 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Principal investigator, Eveline Martens, Maastricht University Medical Center
- Investigators
- Margriet S Westerterp-Plantenga, Prof. dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646749
- Sponsor's protocol ID
- NL41371
- Status last verified
- Jul 2013
- First submitted
- 16 Jul 2012
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Simpson SJ, Raubenheimer D. Obesity: the protein leverage hypothesis. Obes Rev. 2005 May;6(2):133-42. doi: 10.1111/j.1467-789X.2005.00178.x.
PubMed 15836464Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41.
PubMed 16002798Griffioen-Roose S, Mars M, Siebelink E, Finlayson G, Tome D, de Graaf C. Protein status elicits compensatory changes in food intake and food preferences. Am J Clin Nutr. 2012 Jan;95(1):32-8. doi: 10.3945/ajcn.111.020503. Epub 2011 Dec 7.
PubMed 22158729Gosby AK, Conigrave AD, Lau NS, Iglesias MA, Hall RM, Jebb SA, Brand-Miller J, Caterson ID, Raubenheimer D, Simpson SJ. Testing protein leverage in lean humans: a randomised controlled experimental study. PLoS One. 2011;6(10):e25929. doi: 10.1371/journal.pone.0025929. Epub 2011 Oct 12.
PubMed 22022472Mikkelsen PB, Toubro S, Astrup A. Effect of fat-reduced diets on 24-h energy expenditure: comparisons between animal protein, vegetable protein, and carbohydrate. Am J Clin Nutr. 2000 Nov;72(5):1135-41. doi: 10.1093/ajcn/72.5.1135.
PubMed 11063440Martens EA, Tan SY, Mattes RD, Westerterp-Plantenga MS. No protein intake compensation for insufficient indispensable amino acid intake with a low-protein diet for 12 days. Nutr Metab (Lond). 2014 Aug 20;11:38. doi: 10.1186/1743-7075-11-38. eCollection 2014.
PubMed 25183991Martens EA, Tan SY, Dunlop MV, Mattes RD, Westerterp-Plantenga MS. Protein leverage effects of beef protein on energy intake in humans. Am J Clin Nutr. 2014 Jun;99(6):1397-406. doi: 10.3945/ajcn.113.078774. Epub 2014 Apr 23.
PubMed 24760974
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beef Protein Consumption on Energy Intake - The Protein Leverage Hypothesis
- ClinicalTrials.gov ID
- NCT01646749
- Acronym / sponsor ID
- NL41371
- Conditions
- Obesity, Severe Overweight
- Keywords
- Energy intake, Beef protein, Satiety, Protein leverage hypothesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Jul 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 ad libitum daily energy intake, body weight changes and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, body mass index (BMI) and fat mass and obesity-associated (FTO) gene alleles.
Detailed description
The protein leverage hypothesis requires specific evidence whether energy intake would depend on a possible protein intake target in humans. Meat protein as complete protein may show most beneficial effects on variables regarding food intake regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein intake of 5 energy percent (En%) | Experimental | Dietary Supplement: Differences in protein content (En%) of meals |
| Protein intake of 15 En% | Experimental | Dietary Supplement: Differences in protein content (En%) of meals |
| Protein intake of 30 En% | Experimental | Dietary Supplement: Differences in protein content (En%) of meals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- Age 18-70 years
- BMI 18-35 kg/m2
- Non-smoking
- Weight stable
Key exclusion criteria (4 listed)
- Smoking
- Use of medication
- More than moderate alcohol consumption
- Vegetarian
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 (En%) of mealsAlso: All food items will be commercial available.The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content. | Dietary supplement | Protein intake of 15 En%, Protein intake of 30 En%, Protein intake of 5 energy percent (En%) |
Primary outcome
Body weight change
Time frame: 11 days
Body weight will be measured on day 1, 6 and 12. Subsequently, the change in body weight over time will be calculated.
Appetite profile
Time frame: 12 consecutive days
Appetite profile will be measured by means of questionnaires: visual analogue scales (VAS). Area under the curve (AUC) will be calculated over 12 consecutive days.
Energy intake
Time frame: 12 consecutive days
Total energy intake over 12 days will be determined for each subject by adding energy intake during meals to energy intake from snack consumption.
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 11 Jul 2013.
- Background: PubMed 15836464Simpson SJ, Raubenheimer D. Obesity: the protein leverage hypothesis. Obes Rev. 2005 May;6(2):133-42. doi: 10.1111/j.1467-789X.2005.00178.x.
- Background: PubMed 16002798Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41.
- Background: PubMed 22158729Griffioen-Roose S, Mars M, Siebelink E, Finlayson G, Tome D, de Graaf C. Protein status elicits compensatory changes in food intake and food preferences. Am J Clin Nutr. 2012 Jan;95(1):32-8. doi: 10.3945/ajcn.111.020503. Epub 2011 Dec 7.
- Background: PubMed 22022472Gosby AK, Conigrave AD, Lau NS, Iglesias MA, Hall RM, Jebb SA, Brand-Miller J, Caterson ID, Raubenheimer D, Simpson SJ. Testing protein leverage in lean humans: a randomised controlled experimental study. PLoS One. 2011;6(10):e25929. doi: 10.1371/journal.pone.0025929. Epub 2011 Oct 12.
- Background: PubMed 11063440Mikkelsen PB, Toubro S, Astrup A. Effect of fat-reduced diets on 24-h energy expenditure: comparisons between animal protein, vegetable protein, and carbohydrate. Am J Clin Nutr. 2000 Nov;72(5):1135-41. doi: 10.1093/ajcn/72.5.1135.
- Derived from this study: PubMed 25183991Martens EA, Tan SY, Mattes RD, Westerterp-Plantenga MS. No protein intake compensation for insufficient indispensable amino acid intake with a low-protein diet for 12 days. Nutr Metab (Lond). 2014 Aug 20;11:38. doi: 10.1186/1743-7075-11-38. eCollection 2014.
- Derived from this study: PubMed 24760974Martens EA, Tan SY, Dunlop MV, Mattes RD, Westerterp-Plantenga MS. Protein leverage effects of beef protein on energy intake in humans. Am J Clin Nutr. 2014 Jun;99(6):1397-406. doi: 10.3945/ajcn.113.078774. Epub 2014 Apr 23.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 (En%) of meals in people with Obesity and Severe 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 5 inclusion and 4 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 11 Jul 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?
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 weight change (time frame: 11 days). 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 NCT01646749, which also lists 7 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 11 Jul 2013.