Meal Replacement Study

Study of Meal Replacement with Formula Diet in achieving weight loss and improved metabolic control in people with type 2 diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000248662

Enrollment

Registered

2005-08-31

Start date

2005-06-21

Completion date

2005-08-01

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Mean (± SEM) weight loss adjusted for baseline values was significantly greater in the meal replacement group (n=20) than the control group (n=21) at three months (4.7± 0.8 vs 1.3 ± 0.8 kg, P=0.007) and at six months (5.0± 5.2 vs 1.5± 5.2 kg, P=0.04) (Figure 1). The reduction in waist circumference was 1.4 cm greater in the meal replacement group than the control group at six months, but this difference was not significant. BMI reduced by 1.8kg/m2 in the meal replacement group and by 0.6kg/m2 in the control group (P=0.05).

Interventions

Participants will be randomised to either group A (diet) or B (meal replacement) for a period of six months. Group A will receive conventional low calorie diet and physical activity guidance once per month during the six months and Group B will receive the same advice and in addition replace one meal each day with a meal replacement, Microdiet (MD).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Healthy volunteers

Inclusion criteria

Type 2 diabetes. Body mass index > 29kg/m2.

Exclusion criteria

Severe underlying disease prohibiting low calorie diet therapyAllergy to MDPregnant or breastfeedingNeed for protein restrictionGP considers the participant inappropriate.

Outcome results