ObesityNCT00356785
Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention.
A study testing health education, food supplementation and food supplementation combined with physical activity program in people with Obesity and Metabolic Syndrome, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 34 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- health education, food supplementation and food supplementation combined with physical activity program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Dec 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital, Department for Rehabilitation, Prevention and Sports Medicine
Freiburg im Breisgau, 79106
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- health education, food supplementation, food supplementation combined with physical activity program
- Keywords
- lifestyle, diet, exercise, physical activity, obesity
- Medical subject headings
- Obesity, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
food supplementationBehavioural
food supplementation combined with physical activity programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight loss of more than 5%
body weight loss of more than 10%
Secondary outcomes (6)
reduction of body fat
change of muscle mass
change in blood pressure
change in lipids
change in fasting blood glucose
change in weight circumference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startJan 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Almased Wellness GmbH
- Investigators
- Aloys Berg, Prof.Dr., Study director, University Hospital, Department for Rehabilitation, Prevention and Sports Medicine, Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356785
- Sponsor's protocol ID
- 230/01
- Status last verified
- Apr 2006
- First submitted
- 25 Jul 2006
- Last updated
- 26 Jul 2006
- Results posted
- No
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.
PubMed 15303108Koohkan 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.
PubMed 24618460
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00356785
- Acronym / sponsor ID
- 230/01
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- lifestyle, diet, exercise, physical activity, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Almased Wellness GmbH
- Study start
- Jan 2001
- Study completion
- Dec 2001
- First posted
- 26 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 34 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health education | Behavioural | – |
| food supplementation | Behavioural | – |
| food supplementation combined with physical activity program | Behavioural | – |
Primary outcome
body weight loss of more than 5%
body weight loss of more than 10%
6 secondary outcomes
reduction of body fat
change of muscle mass
change in blood pressure
change in lipids
change in fasting blood glucose
change in weight circumference
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2006.
- Results publication: PubMed 15303108Deibert 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.
- Derived from this study: PubMed 24618460Koohkan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aloys Berg, Prof.Dr. study director
University Hospital, Department for Rehabilitation, Prevention and Sports Medicine, Freiburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education, food supplementation and food supplementation combined with physical activity program in people with Obesity and Metabolic Syndrome, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight loss of more than 5%. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356785, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2006.