What this trial studies
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.
Conditions in scope
- Overweight
Interventions
- Nutritional counseling (Other) — 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-3 months (Dietary Supplement) — 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…
- Equikilon-6 months (Dietary Supplement) — 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…
Who can join
Women only · Adults (Child, Adult, Older Adult)
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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Pavia | Fondazione IRCCS Policlinico San Matteo | Unknown |
Status & timeline
- Overall status: Terminated
- Study type: Interventional
- Phase: N/A
- Start date: 2016-09
- Primary completion: 2019-09
- Last update posted: 2025-05-01
- First posted: 2016-09-02
Sponsor & contact
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia (Other)
Collaborators: Leonardo Medica Srl
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Body weight (3 months)
Difference in change in body weight between patients receiving the experimental product and those not assigned to its use
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT02887950 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.