Administration of a dietary supplement ( N-oleyl-phosphatidylethanolamine and epigallocatechin-3-gallate formula) enhances compliance with diet in healthy overweight subjects: a randomized controlled trial.
What this study found
The NOPE-EGCG formula improved adherence to the prescribed diet and several related outcomes versus placebo, but it did not produce significantly greater weight loss over 8 weeks. Compliance with the diet was achieved by 67 (94%) in the NOPE-EGCG group versus 49 (73%) in placebo (P=0.001), and dropout was 6% versus 27% (P=0.001). The supplement also improved insulin resistance (P<0.001), fullness/satiety (P=0.05), depressive symptoms on the Beck Inventory Scale (mean change -4.21 vs -1.36; treatment effect -2.85, 95% CI -4.78 to 0.91; P=0.005), and binge eating severity on the Binge Eating…
- Study & population
- Randomized controlled trial in healthy overweight adults of both sexes in Italy.
- Intervention
- The active supplement was PhosphoLEANe, taken orally as one capsule twice daily before lunch and dinner for 8 weeks, alongside a prescribed low-energy diet.
- Key limitation
- The intervention was tested over only 8 weeks, so durability of effects and longer-term weight outcomes remain uncertain.
View source
Open PDFOriginal abstract
Many studies have found that N-oleyl-ethanolamine (NOE), a metabolite of N-oleyl-phosphatidylethanolamine (NOPE), and epigallocatechin-3-gallate (EGCG) inhibit food intake. The main aim of this study was to evaluate the efficacy of 2 months of administration of an oily NOPE-EGCG complex (85 mg NOPE and 50 mg EGCG per capsule) and its effect on compliance with diet in healthy, overweight people. Secondary end-points of the study were to compare body composition, metabolic parameters, sensation of appetite, depressive symptoms and severity of binge eating. Using a parallel-arm, double-blind, placebo-controlled design, 138 healthy, overweight women (106) and men (thirty-two) were randomly assigned to one of two groups: (1) the treatment group (seventy-one patients: fifty-three females, eighteen males) taking two capsules per day of an oral supplement or (2) the placebo group (sixty-seven patients: fifty-three females, fourteen males). Both groups observed a 3344 kJ/d energy restriction. All parameters were assessed both before onset and after 2 months on the supplement. Dropout was 6 % in the NOPE-EGCG group and 27 % in the placebo group (P < 0.001). The treatment induced a significant weight reduction in both groups ( - 3.28 kg and - 2.67 kg in NOPE-EGCG and placebo, respectively); the weight changes were not significantly different between the groups. NOPE-EGCG treatment improved insulin resistance (P < 0.001), the sensation feelings of fullness (P < 0.05), depressive symptoms (P < 0.004) and severity of binge eating (P < 0.0001).