Dietary Protein Requirements on Unbalanced Diets

Obesity Clinical Trial

Official title:

Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320189
• Other study ID #: NL36167
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: July 10, 2013
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Differences in protein content of meals
Differences in protein content (energy percent) of meals

Locations

Country	Name	City	State
Netherlands	Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

Simpson SJ, Raubenheimer D. Obesity: the protein leverage hypothesis. Obes Rev. 2005 May;6(2):133-42. Review. — View Citation

Sørensen 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. — View 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 conc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy intake		12 consecutive days	No
Primary	protein intake		12 consecutive days	No
Primary	energy balance		12 consecutive days	No
Primary	appetite profile		12 consecutive days	No