NCT01646749

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

July 16, 2012

Last Update Submit

July 10, 2013

Conditions

Keywords

Energy intakeBeef proteinSatietyProtein leverage hypothesis

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    12 consecutive days

Study Arms (3)

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

Interventions

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.

Also known as: All food items will be commercial available.
Protein intake of 15 En%Protein intake of 30 En%Protein intake of 5 energy percent (En%)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Age 18-70 years
  • BMI 18-35 kg/m2
  • Non-smoking
  • Weight stable

You may not qualify if:

  • Smoking
  • Use of medication
  • More than moderate alcohol consumption
  • Vegetarian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6200 MD, Netherlands

Location

Related Publications (7)

  • 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.

    PMID: 15836464BACKGROUND
  • 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.

    PMID: 16002798BACKGROUND
  • Griffioen-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.

    PMID: 22158729BACKGROUND
  • Gosby 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.

    PMID: 22022472BACKGROUND
  • Mikkelsen 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.

    PMID: 11063440BACKGROUND
  • 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.

  • Martens 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.

MeSH Terms

Conditions

ObesityOverweight

Interventions

Meals

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Margriet S Westerterp-Plantenga, Prof. dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 20, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations