- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00356785
Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention.
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.
Study Overview
Status
Conditions
Detailed Description
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Freiburg, Germany, 79106
- University Hospital, Department for Rehabilitation, Prevention and Sports Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible participants must have overweight with a BMI between 27,5 and 35 kg/m²
- The participants must be able to participate in a physical activity program
- The participants must be willing to participate in the program for 1 year
- Written informed consent must be given to accept randomization to either of the intervention groups
Exclusion Criteria:
- Participants who do not meet all entry criteria
- BMI > 35,0 kg / m²
- Performance capacity < 75 w for 2 min
- Subjects younger than 35 yrs (with reference age at 1st Jan 2002: 34.5 yrs) or older than 65 yrs (with reference age at 1st 2002: 65.5 yrs)
- Absolute or relative contraindications to exercise testing of the ACSM
- Persons unable or with restrictions to participate in a regular physical activity program because of any disease (e.g. history of CHD, arrhythmia, valvular heart disease, arthritis of major joints)
- Severe hypertension systolic BP of > 200 mm Hg and or diastolic BP of > 105 mm Hg at rest
- Persons with established insulin dependent diabetes mellitus (IDDM)
- Persons with a disease of the liver or the kidneys prohibiting high protein intake
- Persons with a disease of the thyroid gland or taking thyroid hormones
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
body weight loss of more than 5%
|
body weight loss of more than 10%
|
Secondary Outcome Measures
Outcome Measure |
---|
reduction of body fat
|
change of muscle mass
|
change in blood pressure
|
change in lipids
|
change in fasting blood glucose
|
change in weight circumference
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Aloys Berg, Prof.Dr., University Hospital, Department for Rehabilitation, Prevention and Sports Medicine, Freiburg, Germany
Publications and helpful links
General 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. doi: 10.1038/sj.ijo.0802765.
- Koohkan S, Schaffner D, Milliron BJ, Frey I, Konig D, Deibert P, Vitolins M, Berg A. The impact of a weight reduction program with and without meal-replacement on health related quality of life in middle-aged obese females. BMC Womens Health. 2014 Mar 12;14(1):45. doi: 10.1186/1472-6874-14-45.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 230/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on health education
-
Federal University of PelotasRecruiting
-
University of PretoriaUnknown
-
Universiti Sains MalaysiaNot yet recruitingKnowledge, Attitudes, Practice | Early Childhood Caries
-
Junyan ZhaoActive, not recruitingTumor Chemotherapy PatientsChina
-
Tianjin HospitalCompletedLumbar Disc HerniationChina
-
Federal University of PelotasRecruitingBreast Cancer FemaleBrazil
-
Taipei Medical UniversityActive, not recruiting
-
Chang Gung University of Science and TechnologyEnrolling by invitation
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletedEarly Detection of CancerTurkey
-
University of WashingtonNational Institute on Aging (NIA)RecruitingOsteo Arthritis KneeUnited States