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

Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Overweight Menopausal Women: a Pragmatic, Randomised Clinical Trial.

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.

Study Overview

• Status: Terminated
• Conditions: Overweight
• Intervention / Treatment: Other: Nutritional counseling; Dietary supplement: Equikilon-3 months; Dietary supplement: Equikilon-6 months

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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-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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Difference in change in body weight between patients receiving the experimental product and those not assigned to its use	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Difference in change in body weight between patients receiving the experimental product for 6 months and those assigned to its use for 3 months	6 months
Insulin resistance	Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product and those not assigned to its use	3 months
LDL cholesterol	Difference in change in LDL cholesterol between patients receiving the experimental product and those not assigned to its use	3 months
Triglycerides	Difference in change in triglycerides between patients receiving the experimental product and those not assigned to its use	3 months
Insulin resistance	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	6 months
LDL cholesterol	Difference in change in LDL cholesterol between patients receiving the experimental product for 6 months and those assigned to its use for 3 months	6 months
Triglycerides	Difference in change in triglycerides between patients receiving the experimental product for 6 months and those assigned to its use for 3 months	6 months
Visceral adiposity	Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product and those not assigned to its use	3 months
Visceral adiposity	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	6 months
Fat free mass	Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product and those not assigned to its use	3 months
Fat free mass	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	6 months
Menopausal symptoms	Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product and those not assigned to its use	3 months
Menopausal symptoms	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	6 months
Quality of life	Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product and those not assigned to its use	3 months
Quality of life	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	6 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Collaborators: Leonardo Medica Srl
• Investigators: Principal Investigator: Riccardo Caccialanza, MD, Fondazione IRCCS Policlinico San Matteo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimated): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight Changes; Overweight; Weight Loss; Body Weight
• Other Study ID Numbers: 20150021742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED