105
Participants
Start Date
March 25, 2004
Primary Completion Date
March 28, 2007
Study Completion Date
March 28, 2007
Meal replacement (MR)
"MR-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d and was advised to replace two meals, i.e. breakfast and dinner, every day with two MR shakes, soups or bars and to prepare their own lunch during 3-month weight loss phase (phase 1).~During 3-month weight stabilization phase (phase 2) MR-S group (MR group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The MR-S group was instructed to continue the implemented nutrition advice of weight loss phase.~Duration: 6 months (phase 1 and phase 2: baseline I - 6.month)"
Control (C)
"During 3-month weight loss phase (phase 1) C-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d without MR for weight control.~During 3-month weight stabilization (phase 2) phase C-S group (C group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The C-S group was instructed to continue the implemented nutrition advice of weight loss phase.~Duration: 6 months (phase 1 and phase 2: baseline I - 6.month)"
Verum
"Verum: Specific micronutrient composition with omega-3 fatty acids (capsules)~Verum group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 verum-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase (phase 3).~Duration: 6 months (6.month / baseline II - 12.month)"
Placebo
"Placebo group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 placebo-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase.~Placebo contains no micronutrients and omega-3 fatty acids.~Duration: 6 months (6.month / baseline II - 12.month)"
Collaborators (1)
FomMed HealthCare AG
UNKNOWN
Bonn Education Association for Dietetics r.A., Cologne, Germany
INDUSTRY