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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

Brief Summary:
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: diet and lifestyle program Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: The University of Michigan PCOS Intervention Using Nutritional Ketosis
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: complete diet and lifestyle program 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).




Primary Outcome Measures :
  1. Weight change [ Time Frame: 4 months ]
    Measured with percent body weight change


Secondary Outcome Measures :
  1. HbA1c change [ Time Frame: 4 months ]
    Measured with change in HbA1c


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on sex.
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03987854


Contacts
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Contact: Laura Saslow, PhD 734-764-7836 saslowl@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alison O'Brien    734-763-1997    alisonob@umich.edu   
Sponsors and Collaborators
University of Michigan

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Responsible Party: Laura Saslow, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03987854     History of Changes
Other Study ID Numbers: HUM00113697
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Laura Saslow, University of Michigan:
nutrition

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases