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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Terminated

Conditions: Overweight

Treatments: Dietary Supplement: Equikilon-6 months; Other: Nutritional counseling; Dietary Supplement: Equikilon-3 months

Study type: Interventional

Funder types: Other

Identifiers

NCT02887950

20150021742

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• menopause of recent onset
• overweight (body mass index ≥ 25) or weight gain ≥ 10% after menopause
• written informed consent

Exclusion criteria

• use of Orlistat
• cancer diagnosis
• unavailability to planned measurements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 3 patient groups

Nutritional counseling

Active Comparator group

Description:

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

Treatment:

Other: Nutritional counseling

Equikilon-3 months

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Equikilon-3 months

Equikilon-6 months

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Equikilon-6 months