Dietary Protein Requirements on Unbalanced Diets

NCT ID: NCT01320189

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Protein intake of 5 energy percent

Group Type EXPERIMENTAL

Differences in protein content of meals

Intervention Type DIETARY_SUPPLEMENT

Differences in protein content (energy percent) of meals

Protein intake of 15 energy percent

Group Type EXPERIMENTAL

Differences in protein content of meals

Intervention Type DIETARY_SUPPLEMENT

Differences in protein content (energy percent) of meals

Protein intake of 30 energy percent

Group Type EXPERIMENTAL

Differences in protein content of meals

Intervention Type DIETARY_SUPPLEMENT

Differences in protein content (energy percent) of meals

Interventions

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Differences in protein content of meals

Differences in protein content (energy percent) of meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eveline Martens

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margriet S. Westerterp-Plantenga, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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

Maastricht, Maastricht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 15836464 (View on PubMed)

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.

Reference Type RESULT
PMID: 18239565 (View on PubMed)

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.

Reference Type RESULT
PMID: 16002798 (View on PubMed)

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.

Reference Type RESULT
PMID: 20847729 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25183991 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23221572 (View on PubMed)

Other Identifiers

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NL36167

Identifier Type: -

Identifier Source: org_study_id

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