Overweight
Conditions
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.
Interventions
OTHERNutritional 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_SUPPLEMENTEquikilon-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_SUPPLEMENTEquikilon-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.
Sponsors
Leonardo Medica Srl
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 3 months | Difference in change in body weight between patients receiving the experimental product and those not assigned to its use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | 3 months | Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product and those not assigned to its use |
| LDL cholesterol | 3 months | Difference in change in LDL cholesterol between patients receiving the experimental product and those not assigned to its use |
| Triglycerides | 3 months | Difference in change in triglycerides between patients receiving the experimental product and those not assigned to its use |
| 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 |
| Fat free mass | 3 months | 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 |
| Menopausal symptoms | 3 months | 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 |
| Quality of life | 3 months | 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 |
| Visceral adiposity | 3 months | Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product and those not assigned to its use |
Countries
Italy
Outcome results
None listed