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The University of Michigan PCOS Intervention Using Nutritional Ketosis

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
diet and lifestyle program
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring nutrition

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

complete diet and lifestyle program

Arm Description

Outcomes

Primary Outcome Measures

Mean Percent Body Weight Loss
Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) *100.

Secondary Outcome Measures

HbA1c Change
percentage of glycosylated hemoglobin

Full Information

First Posted
June 12, 2019
Last Updated
October 22, 2022
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03987854
Brief Title
The University of Michigan PCOS Intervention Using Nutritional Ketosis
Official Title
The University of Michigan PCOS Intervention Using Nutritional Ketosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
complete diet and lifestyle program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
diet and lifestyle program
Intervention Description
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 Measure Information:
Title
Mean Percent Body Weight Loss
Description
Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) *100.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
HbA1c Change
Description
percentage of glycosylated hemoglobin
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions
Description
Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Time Frame
4 months
Title
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair
Description
Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Time Frame
4 months
Title
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight
Description
Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Time Frame
4 months
Title
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility
Description
Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Time Frame
4 months
Title
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms
Description
Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Time Frame
4 months
Title
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability
Description
Scale measures health-related quality-of-life for Women with PCOS with five domains: emotions, body hair, weight, infertility, and menstrual problems. It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Time Frame
4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on sex.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34934978
Citation
Missel AL, O'Brien AV, Maser H, Kanwal A, Bayandorian H, Martin S, Carrigan P, McNamee R, Daubenmier J, Isaman DJM, Padmanabhan V, Smith YR, Aikens JE, Saslow LR. Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study. F S Rep. 2021 Sep 4;2(4):386-395. doi: 10.1016/j.xfre.2021.08.008. eCollection 2021 Dec.
Results Reference
derived

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The University of Michigan PCOS Intervention Using Nutritional Ketosis

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