Trial document




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  DRKS00006811

Trial Description

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Title

The ALMASED Concept against Overweight and Obesity and Related Health Risk (ACOORH),
Evaluation of Almased on body composition and co-morbidities in non-diabetic, viscerally fat-distributed overweight or obese patients with at least one additional co-morbidity and with a special focus on the pre-diabetic state.

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Trial Acronym

ACOORH

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URL of the Trial

http://in Bearbeitung

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Brief Summary in Lay Language

It is the aim of this clinical study to investigate the influence of therapeutic lifestyle changes (TLC) which consist of dietary changes induced by meal replacement or of changes in dietary and physical activity behaviour. It has been shown that both types are able to improve body composition and metabolic regulations as well as items of weight balance significantly. As a result of the trial the effectiveness of the tested meal replacement product on regulation in weight and metabolic control as well as application safety should be confirmed.

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Brief Summary in Scientific Language

Obesity has dramatically increased in the majority of European countries during the past decades. In regard to associated risk facors, public health authorities and many physicians recommend weight loss and lifestyle changes as important therapeutic strategies for those who are obese or overweight with co-morbid conditions.

Within the scope of the designed controlled and randomised trial it should be documented that the application of a meal replacement product which is characterised by its low-glycemic and soy-protein-rich properties (Almased) leads to significant improvements in the metabolic control (body weight, fat mass, HbA1c) in overweight and obese subjects; meal replacement should be used over a period of 26 weeks together with a telemonitoring concept.

576 overweight patients (BMI 27-35; 21-65 y) who fulfill at least one item of he metabolic syndrom, living in Western Europe (12 sudy centres) should be included in the trial using local advertisment. The participants will be randomised into two groups. All participants will receive an electronic balance as well as stepcounter; data will be transfered into a statistic portal to be analysed continuously. The intervention group will additionally use a meal replacement therapy (Almased) for 26 weeks. At pre-start, after 4, 12, 26 and at the end of the study (after 52 weeks) parameters of body composition and metabolic control as well as of dietary and activity behaviour and health related quality of life should be documented in clinical controls in a defined form for all study centres.

As a result of these controls it has to be proven in this sample of overweight and prediabetic sample that lifestyle changes in combination with a meal replacement regimen of a low-glycemic and soy-protein-rich product is more effective in improving body composiion and metabolic items, e.g. HbA1c, than life style changes alone.




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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006811
  •   2014/10/14
  •   [---]*
  •   yes
  •   Approved
  •   216/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   E66.0 -  Obesity due to excess calories
  •   R73.0 -  Abnormal glucose tolerance test
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Interventions/Observational Groups

  •   Therapeutic life style intervention in combination with meal replacement (Almased):
    Participants of arm-1 will received a low-glycemic, protein-rich soy-yoghurt-honey-product for meal-replacment (1. week 3x daily; 2.-4. week 2x daily; 5.-26. week 1x daily for dinner) in addition to verbally and written given instructions for lifestyle changes in dietary and activity behaviour; the portion of the given meal-replacement is calculated in relation to normal weight (NW) as 1 g Almased-powder per kg NW per meal; changes in body weight as well as in daily activities will be documented by telemonitoring.

  •   Therapeutic life style intervention without meal replacement:
    Participants of arm-2 will receive verbally and written given instructions for lifestyle changes in dietary and activity behaviour; changes in body weight as well as in daily activities will be documented by telemonitoring.
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Characteristics

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

total body weight (pre-start, after 4, 12, 26 and 52 weeks)

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Secondary Outcome

body fat and lean body mass (BIA)
fasting blood glucose, fasting insulin level and insulin resistance (HOMA), HbA1c, leptin, ApoB (clinical routine methods) (pre-start, after 4, 12, 26 and 52 weeks)

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Countries of Recruitment

  •   Germany
  •   France
  •   Switzerland
  •   United Kingdom
  •   Austria
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/01/19
  •   576
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   65   Years
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Additional Inclusion Criteria

• Age: 21-65 years
• waist circumference ≥ 102cm for males and ≥ 88 cm for females
• BMI 27-35 kg/m2
• with at least one additional co-morbidity of the metabolic syndrome:
- fasting blood glucose of 100-126 mg/dl
- and/or triglycerides of 150-400 mg/dl
- and/or low HDL cholesterol (<40 mg/dl)
- and/or hypertension (anti-hypertensive therapy or untreated systolic blood pressure of 140-160 and/or diastolic blood pressure of 90-100 mmHg)
• Willingness to participate: Participants must be willing to be randomized to either Almased or the Lifestyle Intervention and to follow the protocol to which they have been assigned.

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Exclusion Criteria

- Inability to be physically moderately active due to illness (e.g., chronic heart disease, arrhythmia or heart rate at rest >100/min, valvular heart disease, arthritis of larger joints, etc.)
- Inability to perform physical exercise according to AHA/ACSM criteria
- Total body weight > 141 kg
- Impaired motor skills and / or load-bearing capacity of the supporting and musculoskeletal system
- Severe (rest) hypertension (RRsyst >165 and / or RRdiast >115 mmHg)
- Presence of diabetes mellitus type 1
- Presence of diabetes mellitus type 2 (HbA1c > 6.5%)
- Chronic renal failure (dialysis patient or creatinine >1.4 or 1.5 mg/dL (m/f)
- Increasing liver function enzymes (ALT or gamma-GT) by more than threefold
- Appetite suppressants, slimming, eating disorder
- Psychiatric disorders with permanent medical supervision
- Currently pregnant or nursing
- Symptoms’ free malignant intervals less than 5 years

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Addresses

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    • Inst, f. Sport u. Sportwisenschaftder Universität Freiburg
    • Mr.  Prof. Dr.  Aloys  Berg 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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    • Westdeutsches Diabetes- und Gesundheitszentrum (WDGZ)
    • Mr.  Prof. Dr.  Stephan  Martin 
    • Hohensandweg 37
    • 40591  Düsseldorf
    • Germany
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    • Inst, f. Sport u. Sportwisenschaftder Universität Freiburg
    • Mr.  Prof. Dr.  Aloys  Berg 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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    • Inst, f. Sport u. Sportwisenschaftder Universität Freiburg
    • Mr.  Prof. Dr.  Aloys  Berg 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Almased GmbH
    • Mr.  André  Trouille 
    • Am Bleeken 6
    • 29553  Bienenbüttel
    • Germany
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Status

  •   Recruiting ongoing
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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.