Ms. Westerterp-plantenga et al., Effects of weekly administration of pegylated recombinant human OB proteinon appetite profile and energy metabolism in obese men, AM J CLIN N, 74(4), 2001, pp. 426-434
Background: Results of leptin administration in mice, rats, and humans prov
ide a rationale for therapeutic augmentation of circulating leptin (OB prot
ein) concentrations in obese humans; this may reduce food intake, increase
metabolic rate, and lower body mass.
Objective: We assessed the effects of weekly subcutaneous pegylated polyeth
ylene glycol (PEG)-OB protein administration on appetite and energy metabol
ism in obese men.
Design: We performed a randomized, double-blind, placebo-controlled trial i
n 30 obese men [body mass index (in kg/m(2)): 34.2 +/-3.6; age: 44.7 +/-7 y
]. Subjects received 20 mg PEG-OB protein/wk for 12 wk while limiting their
energy intake to 2.1 MJ/d.
Results: During treatment, appetite and hunger before breakfast decreased a
nd remained lower in the PEG-OB-protein group, whereas they increased and r
emained higher in the placebo group (P<0.0001). During treatment, hunger de
creased in the PEG-OB-protein group (P<0.05) and cognitive restraint increa
sed in the placebo group (P<0.0001). Neither appetite nor food intake chang
ed significantly during the ad libitum evening meal. Under energy balance c
onditions in the respiration chamber, appetite at the end of treatment was
not significantly different from baseline despite similar, significant redu
ctions in 24-h energy intake, energy expenditure, sleeping metabolic rate,
body mass, fat mass, and fat-free mass (P<0.01 for all) in both groups.
Conclusion: Treatment with PEG-OB protein modified subjective appetite at a
dosage that produced no changes in body composition, energy expenditure, o
r body mass loss relative to placebo treatment, suggesting that PEG-OB prot
ein has central rather than peripheral biological activity in obese men.