Polycystic Ovary Syndrome
Conditions
Keywords
nutrition
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.
Interventions
BEHAVIORALdiet 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).
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Laboratory results will be assessed by a lab not associated with the study team.
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Body Weight Loss | 4 months | Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) \*100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Change | 4 months | percentage of glycosylated hemoglobin |
Other
| Measure | Time frame | Description |
|---|---|---|
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight | 4 months | 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. |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility | 4 months | 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. |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions | 4 months | 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. |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability | 4 months | 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. |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms | 4 months | 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. |
| Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair | 4 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Complete Diet and Lifestyle Program 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). | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Complete Diet and Lifestyle Program |
|---|---|
| Age, Continuous | 31.21 years STANDARD_DEVIATION 5.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 3 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Mean Percent Body Weight Loss
Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) \*100.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | Mean Percent Body Weight Loss | -7.67 percentage of weight | Standard Deviation 6.1 |
p-value: <0.001t-test, 2 sided
Secondary
HbA1c Change
percentage of glycosylated hemoglobin
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | HbA1c Change | -0.21 units of % | Standard Deviation 0.27 |
p-value: 0.001t-test, 2 sided
Other Pre-specified
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair | 1.14 score on a scale | Standard Deviation 1.04 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions | 1.92 score on a scale | Standard Deviation 1.17 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility | 1.08 score on a scale | Standard Deviation 1.43 |
p-value: 0.003t-test, 2 sided
Other Pre-specified
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability | 2.10 score on a scale | Standard Deviation 2.76 |
p-value: 0.002t-test, 2 sided
Other Pre-specified
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms | 1.11 score on a scale | Standard Deviation 1.56 |
p-value: 0.004t-test, 2 sided
Other Pre-specified
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Complete Diet and Lifestyle Program | Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight | 2.52 score on a scale | Standard Deviation 1.7 |
p-value: <0.001t-test, 2 sided