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Clinical Trials/NCT02887950
NCT02887950TerminatedNot Applicable

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

Fondazione IRCCS Policlinico San Matteo di Pavia2 sites in 1 country144 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
144
Locations
2
Primary Endpoint
Body weight

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Female
Accepts 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

Arms & Interventions

Nutritional counseling

Active Comparator

Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

Intervention: Nutritional counseling (Other)

Equikilon-3 months

Experimental

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.

Intervention: Equikilon-3 months (Dietary Supplement)

Equikilon-6 months

Experimental

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.

Intervention: Equikilon-6 months (Dietary Supplement)

Outcomes

Primary Outcomes

Body weight

Time Frame: 3 months

Difference in change in body weight between patients receiving the experimental product and those not assigned to its use

Secondary Outcomes

  • Quality of life(6 months)
  • Visceral adiposity(6 months)
  • Fat free mass(6 months)
  • Menopausal symptoms(6 months)
  • Insulin resistance(6 months)
  • Body weight(6 months)
  • LDL cholesterol(6 months)
  • Triglycerides(6 months)

Investigators

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Riccardo Caccialanza

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

Study Sites (2)

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