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Dietary Protein Requirements on Unbalanced Diets

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Differences in protein content of meals
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Energy intake, Protein requirement, Satiety, Protein leverage hypothesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Protein intake of 5 energy percent

Protein intake of 15 energy percent

Protein intake of 30 energy percent

Arm Description

Outcomes

Primary Outcome Measures

energy intake
protein intake
energy balance
appetite profile

Secondary Outcome Measures

Full Information

First Posted
March 16, 2011
Last Updated
July 10, 2013
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01320189
Brief Title
Dietary Protein Requirements on Unbalanced Diets
Official Title
Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Energy intake, Protein requirement, Satiety, Protein leverage hypothesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein intake of 5 energy percent
Arm Type
Experimental
Arm Title
Protein intake of 15 energy percent
Arm Type
Experimental
Arm Title
Protein intake of 30 energy percent
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Differences in protein content of meals
Intervention Description
Differences in protein content (energy percent) of meals
Primary Outcome Measure Information:
Title
energy intake
Time Frame
12 consecutive days
Title
protein intake
Time Frame
12 consecutive days
Title
energy balance
Time Frame
12 consecutive days
Title
appetite profile
Time Frame
12 consecutive days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margriet S. Westerterp-Plantenga, Prof. dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
15836464
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.
Results Reference
result
PubMed Identifier
18239565
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.
Results Reference
result
PubMed Identifier
16002798
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.
Results Reference
result
PubMed Identifier
20847729
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.
Results Reference
result
PubMed Identifier
25183991
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.
Results Reference
derived
PubMed Identifier
23221572
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.
Results Reference
derived

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Dietary Protein Requirements on Unbalanced Diets

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