Skip to content

Dietary Protein Requirements on Unbalanced Diets

Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01320189
Enrollment
81
Registered
2011-03-22
Start date
2011-05-31
Completion date
2012-04-30
Last updated
2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Energy intake, Protein requirement, Satiety, Protein leverage hypothesis

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.

Interventions

Differences in protein content (energy percent) of meals

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
energy intake12 consecutive days
protein intake12 consecutive days
energy balance12 consecutive days
appetite profile12 consecutive days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026