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Completed

NCT Number: NCT01320189

Dietary Protein Requirements on Unbalanced Diets

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Maastricht, 6200 MD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Differences in protein content of meals

Dietary Supplement

Differences in protein content (energy percent) of meals

Primary outcomes

  1. energy intake

    Time frame: 12 consecutive days

  2. protein intake

    Time frame: 12 consecutive days

  3. energy balance

    Time frame: 12 consecutive days

  4. appetite profile

    Time frame: 12 consecutive days

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Dietary Protein Requirements and Caloric Over-consumption on Unbalanced Diets

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2011
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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