Ketogenic Diet in PCOS With Obesity and Insulin Resistance (VLCKD)

January 25, 2022 updated by: Alessandra Gambineri, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Effect of Very Low Calorie Ketogenic Diet on Obese and Insulin-resistant Women With Polycystic Ovary Syndrome: a Controlled Randomized Trial

The purpose of the VLCKD randomized clinical trial is to demonstrate the superiority of very low calorie ketogenic diet with respect to the standard low calorie diet in reducing body weight and insulin resistance in obese and insulin resistant patients with Polycystic Ovary Syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Consecutive patients coming to the Endocrinology and Diabetes Clinic of the S.Orsola hospital in Bologna with the suspicion of PCOS, during the study period, will be eligible to participate. In the screening phase, patients from the clinic conforming to the inclusion criteria will be invited to participate in the anovulation screening phase, lasting up to 8 weeks, during which measurements of LH, FSH, estradiol, progesterone and a gynecologic ultrasound will be done on 7th, 14th, 21st and 28th day of the presumed ovulatory cycle, or at any time if amenorrhea present. Consenting participants will provide written informed consent.

Following the anovulation screening, the patients will be randomized in two arms of the study: 1. very low calorie ketogenic diet (VLCKD) and the 2. low calorie standard diet (LCD).

The study is open label; thus, patients and investigators will not be blinded to treatment allocation due to the nature of the study intervention.

The group assigned to the VLCKD will follow the VLCKD for 8 weeks, after which they will follow the LCD for the next 8 weeks.

The group assigned to the LCD will follow the LCD for the entire length of the study (16 weeks.)

At the start of the study, after 8 weeks and after 16 weeks, following measurements and tests will be done:

  1. clinical examination with the measurement of height, body mass, circumference at the waist and hip level, arterial systolic and diastolic pressure, heart rate, Ferriman-Gallwey and videodermoscopic evaluation of hirsutism and bioimpedance body composition measurement;
  2. blood will be taken for: lipid profile, hepatic transaminases, fasting glucose, fasting insulin, HbA1c, potassium, sodium, urea, calcium, phosphorus, total proteins, albumins, total bilirubin, uric acid, complete blood count, sex hormone binding globulin (SHBG), liquid chromatography-mass spectrometry measurement of testosterone, androstenedione, DHEA, 17OH-progesterone, 17OH-pregnenolone;
  3. dietary interview;
  4. psychological evaluation using the following questionnaires: Symptom Questionnaire, the Psychosocial index and the Psychological Well-Being scales.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Unit of Endocrinology and Prevention and Care of Diabetes, S.Orsola Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS according to the NIH criteria;
  • Body mass index (BMI) between 30 and 35 kg/m3;
  • HOMA index ≥ 3 (according to formula: (fasting glucose [mmol/L] × fasting insulin [mIU/L])/22.5)
  • Written informed consent.

Exclusion Criteria:

  • Diabetes type 1
  • Exogenous insulin or insulin analogue therapy
  • Obesity caused by endocrine disease other than PCOS
  • Obesity caused by pharmacotherapy
  • Use of a weight-loss diet in the past 3 months
  • Use of contraceptive pills in the past 3 months
  • Severe depression
  • Other psychiatric diseases
  • Alcohol or psychoactive substance abuse
  • Severe hepatic insufficiency
  • Renal calculosis
  • Renal insufficiency
  • Episodes of gout
  • Malignant neoplasia
  • Previous cardiovascular or cerebrovascular events
  • Uncontrolled hypertension
  • Water-electrolyte imbalance
  • Any pharmacotherapy capable of interfering with glucose metabolism
  • Any pharmacotherapy capable of interfering with steroid metabolism
  • Menopause
  • Pregnancy
  • Lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Very low calorie ketogenic diet
Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method
Combination product: Very low calorie ketogenic diet
Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method
Other Names:
  • Pronokal method
Behavioral: Low calorie standard diet
Low calorie standard diet with no specified dietary supplement addition
Active Comparator: Low calorie diet
Control treatment with a low calorie standard diet
Behavioral: Low calorie standard diet
Low calorie standard diet with no specified dietary supplement addition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body mass index
Time Frame: 16 weeks after the start of treatment
Weight and height will be combined to report BMI in kg/m^2
16 weeks after the start of treatment
Change in body composition measured by bioimpedentiometry
Time Frame: 16 weeks after the start of the treatment
Fat mass and lean mass changes will be considered to estimate change in body composition and reported as %
16 weeks after the start of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body mass index
Time Frame: 8 weeks after the start of treatment
Weight and height will be combined to report BMI in kg/m^2
8 weeks after the start of treatment
Change in body composition measured by bioimpedentiometry
Time Frame: 8 weeks after the start of the treatment
Fat mass and lean mass will be considered to estimate change in body composition and reported as %
8 weeks after the start of the treatment
Change in Homeostasis Model Assessment Index
Time Frame: 16 weeks after the start of the treatment
Fasting glucose in mmol/L and fasting insulin in mcU/mL will be combined to report Homeostasis Model Assessment Index
16 weeks after the start of the treatment
Change in frequency of menstrual cycles
Time Frame: 16 weeks after the start of the treatment
Number of menses in the 16 weeks before will be considered to report the frequency of menstrual cycles
16 weeks after the start of the treatment
Change in hirsutism
Time Frame: 16 weeks after the start of the treatment
Modified Ferriman-Gallwey score will be used to measure changes in hirsutism; the minimum and maximum values are 4 and 36 respectively; higher score means a worse outcome
16 weeks after the start of the treatment
Change in plasma concentrations of testosterone
Time Frame: 16 weeks after the start of the treatment
testosterone will be reported in ng/mL
16 weeks after the start of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborators

Pronokal group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Actual)

December 6, 2021

Study Completion (Actual)

December 6, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLCKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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