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.

Randomized controlled trial in healthy overweight adults of both sexes in Italy. Participants were 18 to 50 years old with BMI 25 to 35 and were following a low-energy diet providing a 3344 kJ/d deficit with 25% fat, 60% carbohydrate, and 15% protein.

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. Each capsule contained 85 mg N-oleyl-phosphatidylethanolamine (NOPE) extracted from soya lecithin and 121 mg of dry green tea extract standardized to 50 mg epigallocatechin-3-gallate (EGCG).

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 Scale (mean change -6.41 vs -1.24; treatment effect -5.17, 95% CI -7.51 to -2.83; P=0.000). The formulation was well tolerated, with no serious adverse events over 8 weeks.

The intervention was tested over only 8 weeks, so durability of effects and longer-term weight outcomes remain uncertain. Findings are from healthy overweight adults in a single Italian center, which limits generalizability, and the main benefit was on adherence and symptoms rather than on superior weight loss.