VLCKD: Ketogenic Diet in PCOS With Obesity and Insulin Resistance

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT04801173

Collaborator

Pronokal group (Other)

Enrollment

Location

Arms

9.2

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
PCOS Obesity Insulin Resistance	Combination Product: Very low calorie ketogenic diet Behavioral: Low calorie standard diet	N/A

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:

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;
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;
dietary interview;
psychological evaluation using the following questionnaires: Symptom Questionnaire, the Psychosocial index and the Psychological Well-Being scales.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2021

Actual Primary Completion Date :

Dec 6, 2021

Actual Study Completion Date :

Dec 6, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Body mass index [16 weeks after the start of treatment]
Weight and height will be combined to report BMI in kg/m^2
Change in body composition measured by bioimpedentiometry [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 %

Secondary Outcome Measures

Change in Body mass index [8 weeks after the start of treatment]
Weight and height will be combined to report BMI in kg/m^2
Change in body composition measured by bioimpedentiometry [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 %
Change in Homeostasis Model Assessment Index [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
Change in frequency of menstrual cycles [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
Change in hirsutism [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
Change in plasma concentrations of testosterone [16 weeks after the start of the treatment]
testosterone will be reported in ng/mL

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.