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Effects of a Ketogenic Diet on PCOS Outcomes

NCT04163120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-11-14

No results posted yet for this study

Summary

The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.

Conditions

  • Polycystic Ovary Syndrome

Interventions

OTHER

Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)

The KEMEPHY diet (24-29) is a Mediterranean low calories ketogenic protocol (about 1000/1100 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg) Table 1. Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (30). Liquid herbal extracts were used for their draining /toning activity, useful to reduce some commonly reported light side effects of ketogenic diets as constipation, headache and halitosis.

Sponsors & Collaborators

  • University of Palermo

    collaborator OTHER

  • Universita di Verona

    collaborator OTHER

  • Vita-Salute San Raffaele University

    collaborator UNKNOWN

  • University of Padova

    lead OTHER

Principal Investigators

  • Antonio Paoli, MD · University of Padova

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-03-31
Completion
2017-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163120 on ClinicalTrials.gov