Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women

PHASE3CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

March 25, 2004

Primary Completion Date

March 28, 2007

Study Completion Date

March 28, 2007

Conditions
Overweight and ObesityDyslipoproteinemia
Interventions
DIETARY_SUPPLEMENT

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)"

OTHER

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)"

DIETARY_SUPPLEMENT

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)"

OTHER

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)"

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

FomMed HealthCare AG

UNKNOWN

lead

Bonn Education Association for Dietetics r.A., Cologne, Germany

INDUSTRY

NCT03109834 - Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women | Biotech Hunter | Biotech Hunter