Effect of dietary restraint during and following pegylated recombinant leptin (PEG-OB) treatment of overweight men.
OBJECTIVE
To examine the effect of dietary restraint during and following pegylated recombinant leptin (PEG-OB protein) treatment in overweight men.


METHODS
A randomized double-blind placebo-controlled trial in 24 overweight men (BMI: 28.8+/-0.3 kg/m(2); age: 34.8+/-0.9 y). PEG-OB protein (80 mg) or placebo was administered subcutaneously weekly for 6 weeks, combined with a 2.1 MJ/day energy restriction program. Dietary restraint was determined by the Three-Factor Eating Questionnaire before and after treatment, and after 8 weeks follow-up.


RESULTS
During treatment dietary restraint increased, and general hunger, resting energy expenditure and respiratory quotient decreased similarly in the PEG-OB and the placebo group. With PEG-OB treatment, additional weight loss (P<0.03) was observed. During 8 weeks follow-up, body weight increase was larger in the PEG-OB group compared to placebo (P<0.05), and body weight regain was faster. Body weight regain was inversely correlated with the increase in cognitive dietary restraint during treatment (PEG-OB group: r(2)=0.49, P<0.02; placebo group: r(2)=0.60, P=0.01).


CONCLUSIONS
Although treatment with PEG-OB protein led to a greater body weight loss relative to placebo, weight maintenance thereafter was mainly supported by dietary restraint, which was more effective in the placebo-treated group, resulting in a slower regain of body weight.
Lejeune
M P G M
MP
Department of Human Biology, Maastricht University, Maastricht, The Netherlands. M.Lejeune@HB.UNIMAAS.NL
Hukshorn
C J
CJ
Saris
W H M
WH
Westerterp-Plantenga
M S
MS
D000293:Adolescent; D000328:Adult; D003131:Combined Modality Therapy; D004038:Diet, Reducing; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D020738:Leptin / Q000627:therapeutic use*; D008297:Male; D009765:Obesity / Q000178:diet therapy* / Q000188:drug therapy* / Q000503:physiopathology; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D015430:Weight Gain; D015431:Weight Loss
D020738:Leptin; D011994:Recombinant Proteins; D011092:Polyethylene Glycols