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Energy Expenditure, Sleep and Macronutrients

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Unknown

Conditions

Signs and Symptoms
Nutrition Disorders
Overweight
Overnutrition
Obesity
Body Weight

Treatments

Dietary Supplement: Differences in protein content of meals

Study type

Interventional

Funder types

Other

Identifiers

NCT01551238
NL39152

Details and patient eligibility

About

The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.

Full description

The prevalence of obesity has increased worldwide to epidemic proportions. For long-term treatment success permanent lifestyle changes are necessary with regard to approach to food, physical activity patterns and behavior to emotional stress. Moreover, an association has been shown between sleep disturbance and obesity. Weight loss strategies regarding food intake regulation mainly focused on changing patterns of fat and carbohydrate consumption during the last decades. The role of protein has largely been ignored. However, protein has been observed to increase satiety and energy expenditure to a greater extent than carbohydrate and fat and can therefore reduce energy intake. However, it still has to be confirmed if this effect is permanent or transient over a longer period of time. Moreover, dietary intakes may significantly affect sleep when macronutrient intakes are manipulated. Since sleep deprivation has been recognized as a risk factor for obesity, improving sleep by a change in macronutrient intake would be promising in the treatment of obesity.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy
  • age between 18-35 years
  • BMI 18-27 kg/m2
  • non-smoking
  • weight stable (weight change < 3 kg during the last 6 months)
  • no sleeping problems
  • not using a more than moderate amount of alcohol (> 10 consumptions/wk)
  • not using medication or supplements except for oral contraceptives in women

Exclusion criteria

  • not healthy
  • do not meet the criteria for BMI and age
  • smoking
  • not being weight stable
  • using medication or supplements except for oral contraceptives in women
  • sleeping problems
  • using a more than moderate alcohol consumption
  • pregnant or lactating
  • allergic for the used food items

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Protein intake of 5 energy percent
Experimental group
Treatment:
Dietary Supplement: Differences in protein content of meals
Dietary Supplement: Differences in protein content of meals
Protein intake of 30 energy percent
Experimental group
Treatment:
Dietary Supplement: Differences in protein content of meals
Dietary Supplement: Differences in protein content of meals

Trial contacts and locations

1

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Central trial contact

Eveline A. Martens, Msc.; Hanne K. Gonnissen, Msc.

Data sourced from clinicaltrials.gov

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