A COMPOSITION FOR THE PREVENTION AND TREATMENT OF METABOLIC DISORDERS ASSOCIATED WITH MENOPAUSE AND CLIMACTERIC

Abstract

A pharmaceutical composition or dietary supplement with antioxidant activity, mood- regulating activity and insulin-sensitizing activity, with a consequent reduction of the accumulation of adipose tissue, is described, for use in the prevention and treatment of metabolic disorders associated with menopause and climacteric. The composition of the invention comprises, as active ingredients, a combination of alpha-lipoic acid, curcumin and L-tryptophan.

Claims

1. A pharmaceutical composition or dietary supplement comprising, as the active ingredients, the combination of curcumin, alpha-lipoic acid and L-tryptophan, for use in the treatment and prevention of pathologies associated with climacteric and menopause, said pathologies being selected from the group consisting of glucose-lipid dysmetabolism, body weight modification, general tissue ageing, and combinations thereof, or in the prevention of tumours.

2. The pharmaceutical composition or dietary supplement according to claim 1, comprising a Curcuma longa extract as the curcumin source.

3. The pharmaceutical composition or dietary supplement according to claim 2, wherein said Curcuma longa extract preferably has a curcumin titre of about 95%.

4. The pharmaceutical composition or dietary supplement according to claim 1, in a dosage form comprising from 250 to 400 mg of alpha-lipoic acid, from 200 to 400 mg of Curcuma longa extract and from 100 to 200 mg of L-tryptophan.

5. The pharmaceutical composition or dietary supplement according to claim 4, comprising about 300 mg of alpha-lipoic acid, about 300 mg of Curcuma longa extract and about 150 mg of L-tryptophan.

6. The pharmaceutical composition or dietary supplement according to claim 1, which is in an oral dosage form.

7. The pharmaceutical composition or dietary supplement according to claim 1, for use in oral administration, wherein said use comprises administering from 250 to 800 mg/day of alpha-lipoic acid, from 200 to 800 mg/day of Curcuma longa extract and from 100 to 400 mg/day of L-tryptophan.

8. The pharmaceutical composition or dietary supplement according to claim 1, comprising one or more further active ingredient selected from vitamin C, zinc, preferably zinc bisglycinate, chromium, preferably chromium picolinate, vitamin B5 and vitamin B6.

9. The composition according to claim 1, further comprising pharmaceutically acceptable excipients and/or binders and/or vehicles.

Description

FORMULATION EXAMPLE

1.25 g Tablets

[0034]

TABLE-US-00001 INGREDIENTS mg/tablet Dry extract of Curcuma (Curcuma longa, 300.00 root) 95% titre of curcumin (24%) Lipoic acid 300.00 L-Tryptophan 150.00 Vitamin C 125.00 Zinc bisglycinate 15.63 Pantothenic acid Vitamin B5 9.76 Pyridoxine hydrochloride Vitamin B6 2.886 Chromium picolinate 0.4167

[0035] The recommended dose is one or two tablets per day.

[0036] Experimental Section

[0037] α-Lipoic acid (LA) is a natural compound with effects on the metabolism of adipocytes, which are cells devoted to synthesizing, accumulating and yielding fats. In particular, its effect on 3T3-L1 cells has been studied and it is reported in the literature that LA has dose- and time-dependent lipolytic action (Fernandez-Galilea et al., 2012, Journal of Lipid Research) and stimulates the activity of the mitochondria (Shen et al., 2011, British Journal of Pharmacology), the cellular organelle being involved in producing energy in the form of ATP, in mature adipocytes. In addition, LA inhibits the differentiation of preadipocytes into mature adipocytes (Cho et al., 2003, The Journal of Biological Chemistry).

[0038] An experimental study was performed for the purpose of evaluating the effect of the composition of the above formulation example, referred to hereinbelow as Almetax, in the context of LA, for revealing possible synergism between the components of the mixture.

[0039] In particular, the following analyses were performed:

[0040] 1. Preliminary evaluation of the cytotoxicity of the compound and identification of the treatment dose and treatment times.

[0041] 2. Quantification of ATP production after treatment to evaluate the activation of cell metabolism.

[0042] 3. Quantification of lipolysis. Quantification of the cytoplasmatic accumulation of fats for evaluation of the reabsorption after treatment.

[0043] 4. Quantification of the oxygen free radicals (ROS) produced after treatment for evaluation of the antioxidant effect.

[0044] 5. Evaluation of cell proliferation after treatment to evaluate the de-differentiation.