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

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight

Intervention / Treatment
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* Other: Nutritional counseling
* Dietary Supplement: Equikilon-3 months
* Dietary Supplement: Equikilon-6 months


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional counseling<br>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<br>* Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.<br>|
| Experimental: Equikilon-3 months<br>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<br>* 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.<br>|
| Experimental: Equikilon-6 months<br>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<br>* 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.<br>|

What is the study measuring?
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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 |