Clinical trial NCT02887950: Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause
Official title: Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Overweight Menopausal Women: a Pragmatic, Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Leonardo Medica Srl
First posted: 2016-09-02
Enrollment: 144
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 3 months
Secondary outcomes:
measure: Body weight
timeFrame: 6 months
measure: Insulin resistance
timeFrame: 3 months
measure: LDL cholesterol
timeFrame: 3 months
measure: Triglycerides
timeFrame: 3 months
measure: Insulin resistance
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
measure: Triglycerides
timeFrame: 6 months
measure: Visceral adiposity
timeFrame: 3 months
measure: Visceral adiposity
timeFrame: 6 months
measure: Fat free mass
timeFrame: 3 months
measure: Fat free mass
timeFrame: 6 months
measure: Menopausal symptoms
timeFrame: 3 months
measure: Menopausal symptoms
timeFrame: 6 months
measure: Quality of life
timeFrame: 3 months
measure: Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Riccardo Caccialanza, MD
role: PRINCIPAL_INVESTIGATOR
References: