Dietary Protein Requirements on Unbalanced Diets

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: Differences in protein content of meals

• Registration Number: NCT01320189
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Study Start: 2011-05
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Protein intake of 5 energy percent	Differences in protein content of meals	-
Protein intake of 15 energy percent	Differences in protein content of meals	-
Protein intake of 30 energy percent	Differences in protein content of meals	-

Primary Outcome Measures

Name	Time	Method
protein intake	12 consecutive days
energy balance	12 consecutive days
appetite profile	12 consecutive days
energy intake	12 consecutive days

Trial Locations

Locations (1)

Maastricht University, Department of Human Biology, Nutrition and Toxicology Research Institute Maastricht (NUTRIM); 🇳🇱 Maastricht, Netherlands