Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention.
|First Received Date ICMJE||July 25, 2006|
|Last Updated Date||July 25, 2006|
|Start Date ICMJE||January 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention.|
|Official Title ICMJE||Body Compositional and Endocrine-Metabolic Changes by Long-Term Lifestyle Intervention With Health Education, Diet (Almased®), Physical Activity or a Combination of Diet and Physical Activity in Overweight and Obese Persons.|
Eligible overweight and obese persons will be randomized to one of three controlled groups: 1 group of participants is treated by health education for life style intervention only. The other 2 groups will be included in a dietary program with an individually dosed food supplement (Almased®) for an initial weight reduction for a period of 6 weeks. The following 18 weeks represent the most important phase of weight loss and attitude, the participants take part in 2 different interventions according to their randomization. One group will continue the dietary program, one group will try to achieve and maintain weight reduction by continuing the initial dietary program together with an additional physical activity program. For all intervention groups the following 6 months aim at a further stabilization of weight and attitude, now without defined guidelines of intervention but with the intention to continue the so far practiced change in life style. All participants will be supplied with adequate information and material concerning the desired change in life style.
Obese and adipose participants are randomized to three intervention groups. During the first six weeks of the program, the subjects assigned to the substitutional diet group (SD-G) were instructed to replace two daily meals with a commercially available soy-joghurt-honey preparation (Almased®). During the following 18 weeks, only one daily meal was replaced by the preparation. The dietary intake of fat during this second phase was not to exceed 60g per day. The first 6-week diet contained about 1000 kcal per day for women and 1200 kcal for men, and then, in the following weeks, aimed at a maximum of 1500 kcal for women and 1700 kcal for men. In addition, a second group of subjects were encouraged to additionally attend a 60-minute physical activity endurance program twice weekly. Otherwise, they were to follow the same rules as the substitutional diet group (SD/PA-G).
The lifestyle education group (LE-G) attended, after enrolment, three teaching sessions bi-monthly and had individual consultations during weeks 6, 24 and 48. All sessions were held by experts in nutritional counselling. Subjects received a diet-overview handout, in accordance with the “German Society of Nutrition“ and the ”German Society of Sports Medicine and Prevention“. Prescribed was a moderate-fat, nutrient-balanced reduction diet consisting of 1200 to 1500 kcal per day for women and 1500 to 1800 kcal per day for men, with approximately 60 percent of the calories coming from carbohydrates, 25 percent from fat, and 15 percent from protein.
The data collected at enrolment and after 6, 24 and 48 weeks were body weight, waist and abdominal circumference, self-reported medical history, blood pressure, glucose, insulin, serum lipids and inflammatory markers (C-reactive protein, IL-6). For measurement of body composition, the technique of air displacement plethysmography was used (Bod Pod). Dietary compliance was estimated by 24-hour recalls of dietary consumption.
Endpoints: Body weight loss of 5% and 10 %; Reduction of body fat; Change of muscle mass
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||Deibert P, Konig D, Schmidt-Trucksaess A, Zaenker KS, Frey I, Landmann U, Berg A. Weight loss without losing muscle mass in pre-obese and obese subjects induced by a high-soy-protein diet. Int J Obes Relat Metab Disord. 2004 Oct;28(10):1349-52.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2001|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||34 Years to 65 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Germany|
|NCT Number ICMJE||NCT00356785|
|Other Study ID Numbers ICMJE||230/01|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University Hospital Freiburg|
|Collaborators ICMJE||Almased Wellness GmbH, Germany|
|Information Provided By||University Hospital Freiburg|
|Verification Date||April 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP