E66.0 R73.0
Conditions
Interventions
Group 1: 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-replacm
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.
Group 2: Therapeutic life style intervention without meal replacement:
Participants of arm-2 will receive
changes in body weight as well as in daily activities will be documented by telemonitoring.
Sponsors
Inst, f. Sport u. Sportwisenschaftder Universität Freiburg
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total body weight (pre-start, after 4, 12, 26 and 52 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Austria, France, Germany, United Kingdom
Contacts
Public ContactAloys Berg
Inst, f. Sport u. Sportwisenschaftder Universität Freiburg
Outcome results
None listed