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

Not Applicable

Terminated

• Conditions: Overweight
• Interventions: Dietary Supplement: Equikilon-6 months; Other: Nutritional counseling; Dietary Supplement: Equikilon-3 months

• Registration Number: NCT02887950
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-29
• Study Start: 2016-09
• Study First Posted: 2016-09-02
• Status Verified: 2019-02
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Equikilon-6 months	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.
Nutritional counseling	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.
Equikilon-3 months	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.

Primary Outcome Measures

Name	Time	Method
Body weight	3 months	Difference in change in body weight between patients receiving the experimental product and those not assigned to its use

Secondary Outcome Measures

Name	Time	Method
Quality of life	6 months	Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months
Visceral adiposity	6 months	Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months
Fat free mass	6 months	Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months
Menopausal symptoms	6 months	Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months
Insulin resistance	6 months	Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product for 6 months and those assigned to its use for 3 months
Body weight	6 months	Difference in change in body weight between patients receiving the experimental product for 6 months and those assigned to its use for 3 months
LDL cholesterol	6 months	Difference in change in LDL cholesterol between patients receiving the experimental product for 6 months and those assigned to its use for 3 months
Triglycerides	6 months	Difference in change in triglycerides between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy