Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause

Summary

For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus, hypertension and cardiovascular disease), and several studies have shown that the transition to menopause is associated with adverse changes in body composition. In particular, it is common to observe the accumulation of adipose tissue in the abdominal region which is believed to be an important determinant of the increase in cardiovascular risk.

The first-line strategy for weight management in overweight / obese subjects is the modification of dietary habits and lifestyle in terms of physical activity. However, nowadays, there is also a growing interest in complementary therapies (i.e. herbal supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as resistant starch, epigallocatechin gallate and chlorogenic acid as adjuvants of dietary therapy for overweight.

These nutrients may be an important therapeutic aid for overweight subjects. However, in support of their use, the evidence from good quality trials is limited.

Conditions

• Overweight

Interventions

OTHER

Nutritional counseling

Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

DIETARY_SUPPLEMENT

Equikilon-3 months

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling. Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

DIETARY_SUPPLEMENT

Equikilon-6 months

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling. Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

Sponsors & Collaborators

• Leonardo Medica Srl

  collaborator UNKNOWN

• Fondazione IRCCS Policlinico San Matteo di Pavia

  lead OTHER

Principal Investigators

• Riccardo Caccialanza, MD · Fondazione IRCCS Policlinico San Matteo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• Italy

Study Locations