Clinical trial NCT01320189: Dietary Protein Requirements on Unbalanced Diets
Official title: Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Energy intake
Protein requirement
Satiety
Protein leverage hypothesis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine ad libitum daily energy and protein intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, also as a function of age, gender, BMI and FTO polymorphisms.

Detailed description: Following the protein leverage hypothesis, energy intake may be a derivative of protein intake. Therefore, in response to an unbalanced menu relative to the usual daily intake target, protein intake should be prioritized. Individuals may over-consume carbohydrate and fat of a menu containing a lower ratio of protein to carbohydrate and fat until the daily intake target amount of protein is ingested, and not the target of total energy intake because of a deficit of protein intake. In contrast, individuals may under-consume energy when the menu has an increased protein to carbohydrate and fat ratio. The protein leverage hypothesis requires evidence for why protein intake is more important than carbohydrate or fat in relation to food intake regulation.

Eligibility criteria: Inclusion Criteria:

* BMI 18-35 kg/m2
* age between 18-70 years
* healthy
* non-smoking
* not using a more than moderate amount of alcohol (\> 10 consumptions/wk)
* weight stable (weight change \< 3 kg during the last 6 months)
* not using medication or supplements except for oral contraceptives in women

Exclusion Criteria:

* not healthy
* smoking
* using a more than moderate amount of alcohol
* not being weight stable
* using medication or supplements except for oral contraceptives in women
* do not meet the criteria for BMI and age
* pregnant or lactating
* allergic for the used food items

Primary outcomes:
measure: energy intake
timeFrame: 12 consecutive days
measure: protein intake
timeFrame: 12 consecutive days
measure: energy balance
timeFrame: 12 consecutive days
measure: appetite profile
timeFrame: 12 consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
Study officials:
affiliation: Maastricht University
name: Margriet S. Westerterp-Plantenga, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sorensen A, Mayntz D, Raubenheimer D, Simpson SJ. Protein-leverage in mice: the geometry of macronutrient balancing and consequences for fat deposition. Obesity (Silver Spring). 2008 Mar;16(3):566-71. doi: 10.1038/oby.2007.58. Epub 2008 Jan 17.
citation: Weigle 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.
citation: Leidy HJ, Tang M, Armstrong CL, Martin CB, Campbell WW. The effects of consuming frequent, higher protein meals on appetite and satiety during weight loss in overweight/obese men. Obesity (Silver Spring). 2011 Apr;19(4):818-24. doi: 10.1038/oby.2010.203. Epub 2010 Sep 16.
citation: Martens 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.
citation: Martens EA, Lemmens SG, Westerterp-Plantenga MS. Protein leverage affects energy intake of high-protein diets in humans. Am J Clin Nutr. 2013 Jan;97(1):86-93. doi: 10.3945/ajcn.112.046540. Epub 2012 Dec 5.