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The University of Michigan PCOS Intervention Using Nutritional Ketosis

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ClinicalTrials.gov Identifier: NCT03987854
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Saslow, University of Michigan

Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE July 5, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
Weight change [ Time Frame: 4 months ]
Measured with percent body weight change
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
Weight loss [ Time Frame: 4 months ]
Measured with percent body weight lost
Change History Complete list of historical versions of study NCT03987854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
HbA1c change [ Time Frame: 4 months ]
Measured with change in HbA1c
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
Glycemic Control [ Time Frame: 4 months ]
Measured with change in HbA1c
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2019)
Polycystic Ovary Syndrome Questionnaire (PCOSQ) [ Time Frame: 4 months ]
Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems
Original Other Pre-specified Outcome Measures
 (submitted: June 14, 2019)
PCOS-related quality of life: questionnaire [ Time Frame: 4 months ]
measured with change in Health-Related Quality-of-Life Questionnaire, by Cronin et. al, 1998
 
Descriptive Information
Brief Title  ICMJE The University of Michigan PCOS Intervention Using Nutritional Ketosis
Official Title  ICMJE The University of Michigan PCOS Intervention Using Nutritional Ketosis
Brief Summary The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.
Detailed Description Polycystic ovary syndrome (PCOS) is a common and costly ($4.3 billion/year) endocrine disorder that significantly impairs quality of life and increases the risk of obesity and type 2 diabetes as well as hyperandrogenism, infertility, hyperlipidemia, and cardiovascular disease. Diet and lifestyle weight-loss interventions are recommended as the first-line treatment of PCOS, but experts disagree about which nutritional approach is best. A review of previous diet and lifestyle trials in PCOS did find a slight benefit of lower carbohydrate diets for weight loss, glucose control, insulin, and insulin resistance. This may be because carbohydrate intake leads to increased insulin secretion, which then stimulates ovarian androgen production and inhibits the release of fatty acids from cells, both of which worsen PCOS-related issues. Although lower carbohydrate diets may be helpful, research from other populations with or at risk of type 2 diabetes suggests that prior PCOS studies may have set insufficient carbohydrate reduction targets. The investigators propose that a very-low carbohydrate diet may be needed to especially benefit women with PCOS, as greater carbohydrate reduction should have a larger impact on androgen levels and weight loss. Thus, the goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. Behavioral: positive affect informational materials. They will also be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths, in addition to information about mindfulness and mindful eating techniques.
Masking: None (Open Label)
Masking Description:
Laboratory results will be assessed by a lab not associated with the study team.
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE Behavioral: diet and lifestyle program
Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating).
Study Arms  ICMJE Experimental: complete diet and lifestyle program
Intervention: Behavioral: diet and lifestyle program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • We will include women in one PCOS subtype, those having these two symptoms:

    • Hyperandrogenism - (a) If not on current birth control: hyperandrogenism defined as current elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism (b) if on current birth control: history from the past 10 years of hyperandrogenism defined as past elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism
    • oligomenorrhea-anovulation defined as spontaneous intermenstrual periods of ≥ 45 days or a total of ≤ 8 menses per year.

Participants must also be:

  • overweight or obese (BMI 25-50)
  • be 21-40 years old
  • have regular access to the internet
  • be able to engage in light physical activity
  • willing and able to follow the assigned intervention.

Exclusion Criteria:

  • a non-English speaker
  • inability to complete baseline measurements
  • a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy)
  • pregnant or planning to get pregnant in the next 6 months
  • type 1 or type 2 diabetes
  • baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times normal
  • baseline renal disease defined as BUN > 30 mg/dL or serum creatinine >1.4 mg/dL
  • baseline uncorrected thyroid disease (TSH <0.45 mIU/ML or >4.5 mIU/ML)
  • breastfeeding or less than 6 months post-partum
  • planned or history of weight loss surgery
  • vegan or vegetarian
  • currently enrolled in a weight loss program or other investigative study that might conflict with this research
  • taking medications known to cause weight gain or loss
  • taking hypoglycemic medications other than metformin or medications known to affect metabolism
  • or patients with other etiologies of anovulation and hyperandrogenism, e.g., Cushing's disease, thyroid dysfunction, elevated prolactin levels, signs of congenital adrenal hyperplasia, organic intra cranial lesion such as a pituitary tumor, or suspected adrenal or ovarian tumor secreting androgens.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Participant eligibility is based on sex.
Ages  ICMJE 21 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Saslow, PhD 734-764-7836 saslowl@umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987854
Other Study ID Numbers  ICMJE HUM00113697
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura Saslow, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP