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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006827 |
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Date of registration:
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10/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 - REE study |
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Date of first enrolment:
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29/08/2011 |
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Target sample size:
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76 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00006827 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: basic science
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Ursel
Wahrburg |
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Address:
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Corrensstraße 25
48149
Münster
Germany |
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Telephone:
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0251 83-65444 |
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Email:
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uwahrburg@fh-muenster.de |
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Affiliation:
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Fachhochschule MünsterFachbereich Oecotrophologie-Facility Management |
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Name:
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Ursel
Wahrburg |
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Address:
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Corrensstraße 25
48149
Münster
Germany |
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Telephone:
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0251 83-65444 |
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Email:
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uwahrburg@fh-muenster.de |
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Affiliation:
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Fachhochschule MünsterFachbereich Oecotrophologie-Facility Management |
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Key inclusion & exclusion criteria
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Inclusion criteria: body mass index 27-35 kg/m2, visceral fat distribution (waist ciircumference men > 94 cm, waist circumference women > 80 cm)
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
Age minimum:
19 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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overweight, obesity
E66
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Intervention(s)
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Group 1: 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)
Group 2: 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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Primary Outcome(s)
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Resting energy expenditure at baseline and end (week 12), measurement by indirect calorimetry
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Fachhochschule Münster, Fachbereich Oecotrophologie-Facility Management
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Ethics review
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Status: Approved
Approval date: 28/04/2011
Contact:
ethik-kommission@aekwl.de
Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
+49-251-9292460
ethik-kommission@aekwl.de
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