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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK128205-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This research will test whether a Dietary Approaches to Stop Hypertension (DASH) or a very low-carbohydrate diet better improves outcomes like blood glucose control and body weight for adults with polycystic ovary syndrome.
Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor and a body composition scan (called a dual-energy x-ray absorptiometry or DEXA). Once these enrollment steps are completed and the participants will be randomized to one of two 12-month programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASH diet | Active Comparator | 12-month DASH diet intervention with psychological support |
|
| Very low-carbohydrate diet | Experimental | 12-month very low-carbohydrate diet intervention with psychological support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH diet | Behavioral | Participants in this arm will be taught a DASH diet plus psychological skills to support dietary adherence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | percentage of glycosylated hemoglobin | 0 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent body weight loss | percent change | 0-12 months |
| Change in glycemic variability | This will be measured with an Abbott Libre Pro continuous glucose monitoring device on participants' upper arm and the information on the sensor is blinded to participants. The monitoring device will record participants' glucose levels in the interstitial fluid by a glucose oxidase method every 15 minutes, continuously for 14 days at each time point. The glucose variability and the proportion of time spent in the euglycemic (3-7.8 millimoles per litre (mmol/l)) and hyperglycemic (≥ 11.1 mmol/l for at least 15 minutes) states, following previous standards for interstitial glucose concentrations. |
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Inclusion criteria:
Participants must have the following criteria:
oligomenorrhea-anovulation
and hyperandrogenism
If no medical records to confirm (most recent test from within the last 10 years in range), tests for diagnosis will be ordered:
BMI 25-50 kg/m2 or 23-50 kg/m2 for Asians
Access to internet
Ability to engage in light physical activity
Willingness to be randomized to either dietary approach
Measured HbA1c at baseline of 5.3%-9.0%
Exclusion criteria:
Primary
Ability
Safety
Renal disease: BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL in our screening blood tests or history of kidney stones
untreated eating disorder or unstable serious mental illness (such as depression (score of 20 or greater on the PHQ8), bipolar or schizophrenia with psychosis)
use of warfarin
chronic kidney disease, stage 4 or higher
Any other concerning values in baseline labs (we will plan to send the participant to their PCP and allow the participant to return for later enrollment if labs are no longer concerning) Examples:
any condition for which the study team deems participation to be unsafe or inappropriate
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| Name | Affiliation | Role |
|---|---|---|
| Laura Saslow, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39516828 | Derived | Greenwell S, Jones A, Smith YR, Marriott D, Aikens JE, Padmanabhan V, Saslow LR. Protocol for a randomized comparative effectiveness trial comparing a very low-carbohydrate diet to DASH diet for polycystic ovary syndrome: the SUPER (Supporting Understanding of PCOS Education and Research) trial. Trials. 2024 Nov 9;25(1):750. doi: 10.1186/s13063-024-08583-y. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2025 | Nov 5, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Outcome assessment and data analysis will be masked
| Very low-carbohydrate diet | Behavioral | Participants in this arm will be taught a very low-carbohydrate diet plus psychological skills to support dietary adherence. |
|
| 0 to 12 months |
| Change in percent body fat on DEXA | This will be measured by dual-energy X-ray absorptiometry scan | 0 to 12 months |
| Change in HbA1c | percentage of glycosylated hemoglobin | 0 to 4 months |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |