Trial document





This trial has been registered retrospectively.
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  DRKS00006827

Trial Description

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Title

Effects of an energy-restricted diet with and without physical activity on resting energy expenditure, body composition and endocrine parameters in overweight-to-obese men and women

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Trial Acronym

REE study

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URL of the Trial

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Brief Summary in Lay Language

In the therapy of overweight and obesity, a negative energy balance is the essential prerequisite for body weight reduction. During body weight reduction, a decline in resting energy expenditure (REE) is observed, leading to a decrease in body weight loss rates with increasing duration. The objective of our study was to investigated the effects of a moderate, but regular walking program on body weight and body composition (fat mass, fat-free mass), REE, endocrine and cardiovascular risk parameters in overweight to obese patients fed a hypo-energetic diet in comparison to a control group with the same diet, but without walking program.

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Brief Summary in Scientific Language

In the therapy of overweight and obesity, a negative energy balance is the essential prerequisite for body weight reduction. During body weight reduction, a decline in resting energy expenditure (REE) is observed, leading to a decrease in body weight loss rates with increasing duration. The objective of our study was to investigated the effects of a moderate, but regular walking program on body weight and body composition (fat mass, fat-free mass), REE, endocrine (thyroid hormones, cortisol) and cardiovascular risk parameters (blood pressure, heart rate, parameter of lipid and glucose metabolism) in overweight to obese patients fed a hypo-energetic diet in comparison to a control group with the same diet, but without walking program.

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Organizational Data

  •   DRKS00006827
  •   2014/10/10
  •   [---]*
  •   yes
  •   Approved
  •   2011-148-f-S , Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   overweight, obesity
  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Diet group (control)(diet period: 12 weeks; energy-reduced diet; daily deficit of 500-800 kcal; protein, 21 % of energy; carbohydrates, 44 % of energy; fat, 33 % of energy)
  •   Diet plus exercise group (diet period: 12 weeks; energy-reduced diet; daily deficit of 500-800 kcal; protein, 21 % of energy; carbohydrates, 44 % of energy; fat, 33 % of energy; physical activity program consisting of brisk walking for a total of 3 hours per week with a mean speed of 6 km/h)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Resting energy expenditure at baseline and end (week 12), measurement by indirect calorimetry

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Secondary Outcome

At baseline and end (week 12): body weight, body composition (measurement by bioelectrical impedance analysis), waist and hip circumference, lipid metabolism, glucose, insulin, thyroid hormones

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2011/08/29
  •   76
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   19   Years
  •   50   Years
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Additional Inclusion Criteria

body mass index 27-35 kg/m2, visceral fat distribution (waist ciircumference men > 94 cm, waist circumference women > 80 cm)

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Exclusion Criteria

smoking, pregnancy and lactation, menopause, a history of atherosclerotic, renal, gastrointestinal and endocrine diseases, food allergy or intolerances, and vegetarian or vegan food pattern

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Addresses

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    • Fachhochschule Münster, Fachbereich Oecotrophologie-Facility Management
    • Corrensstraße 25
    • 48149  Münster
    • Germany
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    • Universität Bonn IEL Ernährungsphysiologie
    • Ms.  Priv.-Doz. Dr.  Sarah  Egert 
    • Endenicher Allee 11-13
    • 53115  Bonn
    • Germany
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    • Zentrum für Sportmedizin - Münster
    • Windhorststraße 35
    • 48143  Münster
    • Germany
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    • Fachhochschule MünsterFachbereich Oecotrophologie-Facility Management
    • Ms.  Prof. Dr.  Ursel  Wahrburg 
    • Corrensstraße 25
    • 48149  Münster
    • Germany
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    • Fachhochschule MünsterFachbereich Oecotrophologie-Facility Management
    • Ms.  Prof. Dr.  Ursel  Wahrburg 
    • Corrensstraße 25
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Fachhochschule Münster, Fachbereich Oecotrophologie-Facility Management
    • Corrensstraße 25
    • 48149  Münster
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/05/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.