The University of Michigan PCOS Intervention Using Nutritional Ketosis

NCT03987854 | Completed Phase 1 Results

• 3 other identifiers: HUM00113697P30DK092926K01DK107456
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome

Keywords

nutrition

Outcome Measures

Primary Outcomes (1)

• Mean Percent Body Weight Loss

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

  4 months

Secondary Outcomes (1)

• HbA1c Change

  4 months

Other Outcomes (6)

• Polycystic Ovary Syndrome Questionnaire (PCOSQ): Emotions

  4 months

• Polycystic Ovary Syndrome Questionnaire (PCOSQ): Body Hair

  4 months

• Polycystic Ovary Syndrome Questionnaire (PCOSQ): Weight

  4 months

Study Arms (1)

complete diet and lifestyle program

EXPERIMENTAL

Behavioral: diet and lifestyle program

Interventions

diet and lifestyle program BEHAVIORAL

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).

complete diet and lifestyle program

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Participant eligibility is based on sex.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 34934978 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Laura Saslow
• Organization: University of Michigan

saslowl@umich.edu

(734) 764-7836

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Laboratory results will be assessed by a lab not associated with the study team.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: July 5, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 25, 2022
• Results First Posted: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)