Satiety and amino-acid profile in overweight women after a new treatment using a natural plant extract sublingual spray formulation.
OBJECTIVE
To test the effect on satiety of a formulation comprising plant extracts naturally containing 5-hydroxytryptophan, delivered as sublingual spray (5HTP-Nat Exts), administered five times a day for 2 months.


METHODS
Two-month, randomized, double-blind, placebo-controlled trial.


METHODS
A total of 27 healthy, adult overweight women were randomly assigned to the treatment (14) or the placebo group (13).


METHODS
Visual analog scales were used to assess appetite sensations every day. Moreover, the study evaluated the bioavailability of 5-hydroxytryptophan following sublingual delivery over 8 weeks, by comparing 24-h urinary excretion of 5-hydroxy-3-indoleacetic acid (5-HIAA), determined at baseline and after 2 months. Other secondary end points of the study were to compare body composition, depressive symptoms, severity of binge eating and quality of life. Finally, the study tested whether a single administration of 5HTP-Nat Exts in fasting state has an effect on amino-acid profile and on appetite ratings and whether 5HTP-Nat Exts administered before a fixed test meal has any effect on satiety.


RESULTS
The group using the 5HTP-Nat Exts experienced a significantly greater increase in their sensation of satiety over an 8-week timeframe and in fasting state following administration of 5HTP-Nat Exts than the placebo group did (AUC=305.2 (52.8) vs 236.6 (59.4), mean difference -68.7 (95% confidence interval (CI) -116.2 to -21.2), P=0.007; mean difference in Haber score change 2.5 (95% CI 0.62-3.12, P=0.007)). A difference was observed between the groups for the mean change in 5-HIAA. All the amino acids evaluated after a single administration of 5HTP-Nat Exts were found to be similar. Differences were found for the mean change in body mass index, skinfold thicknesses and hip circumference. The other parameters were found to be similar.


CONCLUSIONS
All these findings suggest that 5HTP-Nat Exts may be safely used to treat the problem of appetite control in overweight women during a weight loss program.
Rondanelli
M
M
Section of Human Nutrition and Dietetics, Faculty of Medicine, Endocrinology and Nutrition Unit, Department of Applied Health Sciences, Azienda di Servizi alla Persona, University of Pavia, Pavia, Italy. serv.nutrizione@asppavia.it
Klersy
C
C
Iadarola
P
P
Monteferrario
F
F
Opizzi
A
A
D006916:5-Hydroxytryptophan / Q000008:administration & dosage* / Q000378:metabolism; D000328:Adult; D000596:Amino Acids / Q000097:blood; D001067:Appetite Depressants / Q000008:administration & dosage*; D001069:Appetite Regulation; D001682:Biological Availability; D004038:Diet, Reducing; D004304:Dosage Forms; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D050177:Overweight / Q000188:drug therapy* / Q000523:psychology; D010936:Plant Extracts / Q000008:administration & dosage*; D012527:Satiation / Q000187:drug effects* / Q000502:physiology; D015431:Weight Loss / Q000187:drug effects*
D000596:Amino Acids; D001067:Appetite Depressants; D004304:Dosage Forms; D010936:Plant Extracts; D006916:5-Hydroxytryptophan