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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04801173
Recruitment Status : Completed
First Posted : March 16, 2021
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Pronokal group
Information provided by (Responsible Party):
Alessandra Gambineri, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2, 2021
Actual Primary Completion Date : December 6, 2021
Actual Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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

  2. 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 %


Secondary Outcome Measures :
  1. 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

  2. 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 %

  3. 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

  4. 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

  5. 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

  6. Change in plasma concentrations of testosterone [ Time Frame: 16 weeks after the start of the treatment ]
    testosterone will be reported in ng/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801173


Locations
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Italy
Unit of Endocrinology and Prevention and Care of Diabetes, S.Orsola Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Pronokal group
Publications:

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Responsible Party: Alessandra Gambineri, Associate Professor, IRCCS Azienda Ospedaliero-Universitaria di Bologna
ClinicalTrials.gov Identifier: NCT04801173    
Other Study ID Numbers: VLCKD
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandra Gambineri, IRCCS Azienda Ospedaliero-Universitaria di Bologna:
Ketogenic diet
Insulin resistance
PCOS
Obesity
Hyperandrogenism
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases