What is the mechanism of action of this treatment?

Common treatments for Polycystic Ovarian Syndrome (PCOS) include dietary interventions like the DASH diet and Very Low-Carbohydrate Diet, which improve blood glucose control and body weight. The DASH diet achieves this through balanced nutrient intake and reduced sodium, while the Very Low-Carbohydrate Diet reduces carbohydrate intake and promotes ketosis. These dietary changes help mitigate insulin resistance and hyperinsulinemia, key factors in PCOS. Additionally, medications like metformin enhance insulin sensitivity, and hormonal therapies regulate menstrual cycles and reduce androgen levels. These treatments collectively address the metabolic and reproductive abnormalities in PCOS, improving overall health and quality of life for patients.

What side effects are associated with this type of intervention?

The DASH diet, aimed at improving blood glucose control and body weight through balanced nutrient intake and reduced sodium, is generally well-tolerated but may cause gastrointestinal discomfort due to increased fiber intake. The Very Low-Carbohydrate Diet, which improves blood glucose control and body weight by reducing carbohydrate intake and promoting ketosis, can lead to initial side effects such as headache, fatigue, and irritability, often referred to as the 'keto flu.' Metformin, a common treatment for PCOS, can cause gastrointestinal issues like nausea, diarrhea, and abdominal discomfort. Berberine, another insulin-sensitizing agent, may also cause gastrointestinal side effects such as constipation, diarrhea, and stomach cramps.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PCOS, focusing on managing insulin resistance, weight, and hormonal imbalances. Metformin, an insulin-sensitizing drug, is commonly used to improve insulin resistance and has shown benefits in weight management and restoring menstrual regularity. Combined oral contraceptives are also approved to manage hyperandrogenism and menstrual irregularities. While specific dietary approaches like the DASH or Very Low-Carbohydrate diets are not FDA-approved treatments, they are recommended as part of lifestyle modifications to improve metabolic outcomes in PCOS patients.

What other types of research exist?

Promising novel alternatives for PCOS patients include: 1) Dietary flaxseed oil rich in omega-3, which has been shown to reduce fasting blood glucose, glycated hemoglobin, and improve lipid profiles. 2) Powdered asparagus bottom-stems and cladophylls, which have demonstrated improvements in blood pressure, glucose metabolism, and lipid profiles. 3) Seaweed supplements, such as Sargassum siliquosum, which have shown potential in normalizing metabolic and cardiovascular responses in high-carbohydrate, high-fat diet models.

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Dietary Intervention

DASH vs Low-Carb Diet for Polycystic Ovary Syndrome (SUPER Trial)

N/A

Recruiting

Led By Laura Saslow, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have spontaneous intermenstrual periods of < 21 days or > 35 days or a total of 8 or fewer menses per year if not on hormonal birth control or birth control that alters menstrual cycle timing

Participants must meet specific testosterone, free testosterone, free androgen index, and hirsutism criteria

Must not have

Patients with a history of type 1 diabetes

Patients with previous bariatric surgery or planning to have bariatric surgery during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two diets, the DASH diet and a very low-carbohydrate diet, to see which one better helps adults with polycystic ovary syndrome (PCOS) manage their blood sugar and weight. The DASH diet focuses on healthy foods to lower blood pressure, while the very low-carb diet cuts down on sugars to control blood sugar and weight.

Who is the study for?

Adults with polycystic ovary syndrome (PCOS) who are overweight or obese, have irregular menstrual cycles, and elevated testosterone levels can join. They must be able to do light exercise, follow one of two diets, and not be on certain medications that affect metabolism or weight.

What is being tested?

The study is testing if a DASH diet or a very low-carbohydrate diet is more effective in improving blood sugar control and reducing body weight in PCOS patients over 12 months. Participants will undergo initial health screenings and then be randomly assigned to one of the dietary programs.

What are the potential side effects?

Potential side effects from changing diets may include temporary digestive discomfort such as bloating or constipation. The DASH diet could lead to increased urination due to higher fluid intake while the very low-carb diet might cause 'keto flu' symptoms like headache, fatigue, and irritability initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My periods are irregular, occurring less than 8 times a year or not within 21-35 days.

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My hormone levels and hair growth match the study's requirements.

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I have irregular or no menstrual periods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of type 1 diabetes.

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I have had or plan to have weight-loss surgery.

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I am not on any glucose-lowering medications except for metformin.

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My irregular periods and high male hormone levels are not due to PCOS.

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I am unable to understand and give consent for treatment.

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I have a blood disorder that affects my HbA1c levels.

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I cannot read, write, or speak English.

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I am not currently in another weight loss program.

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I am taking medication for weight loss or psychostimulants.

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I do not have severe kidney disease, untreated eating disorders, serious mental health issues, or use warfarin.

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I have trouble chewing or swallowing.

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I have gone through menopause or had my ovaries removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in HbA1c

Change in glycemic variability

Change in percent body fat on DEXA

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Very low-carbohydrate dietExperimental Treatment1 Intervention

12-month very low-carbohydrate diet intervention with psychological support

Group II: DASH dietActive Control1 Intervention

12-month DASH diet intervention with psychological support

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Polycystic Ovarian Syndrome (PCOS) include dietary interventions like the DASH diet and Very Low-Carbohydrate Diet, which improve blood glucose control and body weight. The DASH diet achieves this through balanced nutrient intake and reduced sodium, while the Very Low-Carbohydrate Diet reduces carbohydrate intake and promotes ketosis. These dietary changes help mitigate insulin resistance and hyperinsulinemia, key factors in PCOS. Additionally, medications like metformin enhance insulin sensitivity, and hormonal therapies regulate menstrual cycles and reduce androgen levels. These treatments collectively address the metabolic and reproductive abnormalities in PCOS, improving overall health and quality of life for patients.

Evidence for distinctive and intrinsic defects in insulin action in polycystic ovary syndrome.Impaired glucose tolerance in patients with polycystic ovary syndrome (PCOS).Peri-muscular adipose tissue may play a unique role in determining insulin sensitivity/resistance in women with polycystic ovary syndrome.