Trial Outcomes & Findings for The University of Michigan PCOS Intervention Using Nutritional Ketosis (NCT NCT03987854)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

29 participants

Primary outcome timeframe

4 months

Results posted on

2022-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	29
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The University of Michigan PCOS Intervention Using Nutritional Ketosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Complete Diet and Lifestyle Program n=29 Participants 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).
Age, Continuous	31.21 years STANDARD_DEVIATION 5.13 • n=93 Participants
Sex: Female, Male Female	29 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
Mean Percent Body Weight Loss	-7.67 percentage of weight Standard Deviation 6.10

SECONDARY outcome

Timeframe: 4 months

percentage of glycosylated hemoglobin

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
HbA1c Change	-0.21 units of % Standard Deviation 0.27

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions	1.92 score on a scale Standard Deviation 1.17

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair	1.14 score on a scale Standard Deviation 1.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight	2.52 score on a scale Standard Deviation 1.70

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Infertility	1.08 score on a scale Standard Deviation 1.43

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Symptoms	1.11 score on a scale Standard Deviation 1.56

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Complete Diet and Lifestyle Program n=21 Participants 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).
Polycystic Ovary Syndrome Questionnaire (PCOSQ): Menstrual Predictability	2.10 score on a scale Standard Deviation 2.76

Adverse Events

Complete Diet and Lifestyle Program

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Complete Diet and Lifestyle Program n=29 participants at risk 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).
Renal and urinary disorders kidney stones	6.9% 2/29 • 4 months
Eye disorders blurry vision	3.4% 1/29 • 4 months
Musculoskeletal and connective tissue disorders muscle cramping	3.4% 1/29 • 4 months

Additional Information

Laura Saslow

University of Michigan

Phone: (734) 764-7836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place