The Copenhagen PLAFA project: a randomized trial of gastroplasty versus very-low-calorie diet in the treatment of severe obesity (preliminary results).

Consecutive patients, between 18 and 54 years, suffering from morbid obesity (greater than or equal to 60 per cent overweight) are being randomized to either gastroplasty a.m. Gomez or to a very-low-calorie diet (341 kcal, 1.43 MJ) based on a high-value protein powder with an admixture of calcium, phosphate, sodium, chloride, and magnesium. Through a supplementary daily vitamin-mineral capsule and three tablets of potassium chloride the total regime complies with the 1980 RDA. After initial hospitalization, both groups are seen as out-patients. Twenty-eight patients have so far been studied and none has dropped out. Preliminary results show a substantial weight lose without significant differences between the groups.

RCT Entities:   Population Interventions Outcomes