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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02887950
• Other study ID #: 20150021742
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2019

Study information

• Verified date: February 2019
• Source: IRCCS Policlinico S. Matteo
• Contact: Riccardo Caccialanza, MD
• Phone: 00390382501615
• Email: r.caccialanza[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo	Leonardo Medica Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Difference in change in body weight between patients receiving the experimental product and those not assigned to its use	3 months
Secondary	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
Secondary	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
Secondary	LDL cholesterol	Difference in change in LDL cholesterol between patients receiving the experimental product and those not assigned to its use	3 months
Secondary	Triglycerides	Difference in change in triglycerides between patients receiving the experimental product and those not assigned to its use	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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