Polycystic Ovary SyndromePhase 1/2NCT03987854
The University of Michigan PCOS Intervention Using Nutritional Ketosis
A Phase 1/2 study testing diet and lifestyle program in people with Polycystic Ovary Syndrome, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- diet and lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 1 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- have regular access to the internet
- be able to engage in light physical activity
- willing and able to follow the assigned intervention.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- diet and lifestyle program
- Keywords
- nutrition
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and lifestyle programBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| complete diet and lifestyle program | Experimental | Not described Receives: Behavioral: diet and lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Body Weight Loss
Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) *100.
Measured: 4 months
Secondary outcomes (1)
HbA1c Change
percentage of glycosylated hemoglobin
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start5 Jul 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Saslow, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987854
- Sponsor's protocol ID
- HUM00113697
- Other IDs
- P30DK092926, K01DK107456
- Status last verified
- Oct 2022
- First submitted
- 12 Jun 2019
- Last updated
- 25 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34934978
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of Michigan PCOS Intervention Using Nutritional Ketosis
- ClinicalTrials.gov ID
- NCT03987854
- Acronym / sponsor ID
- HUM00113697
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- nutrition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Posted 25 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| complete diet and lifestyle program | Experimental | Behavioral: diet and lifestyle program |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- We will include women in one PCOS subtype, those having these two symptoms:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet and lifestyle programParticipants 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). | Behavioural | complete diet and lifestyle program |
Primary outcome
Mean Percent Body Weight Loss
Time frame: 4 months
Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) *100.
1 secondary outcome
HbA1c Change
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34934978Missel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing diet and lifestyle program in people with Polycystic Ovary Syndrome, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Body Weight Loss (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.