DASH vs Low-Carb Diet for Polycystic Ovary Syndrome

(SUPER Trial)

Overseen By Laura Saslow, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Weight loss drugs, Psychostimulants, Corticosteroids, Warfarin

Disqualifiers: Type 1 diabetes, Menopause, Pregnancy, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 months

214 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are using medications prescribed for weight loss, certain psychostimulants, or glucose-lowering medications other than metformin.

Is the DASH or low-carb diet safe for humans?

Both the DASH diet and low-carb diets, including ketogenic diets, have been studied for various health conditions and are generally considered safe when supervised by healthcare professionals. They can lead to weight loss and improve certain health markers, but individual responses can vary, so it's important to have professional guidance to balance risks and benefits. ^{1 2 3 4 5}

How does the DASH vs Low-Carb Diet treatment for PCOS differ from other treatments?

The DASH diet focuses on reducing insulin resistance and inflammation by emphasizing fruits, vegetables, whole grains, and low-fat dairy, while the low-carb, ketogenic diet aims to improve insulin sensitivity by significantly reducing carbohydrate intake. These dietary approaches are unique compared to traditional PCOS treatments that often focus on hormonal therapy and fertility, offering a non-drug option that targets metabolic factors like obesity and insulin resistance. ^{3 4 6 7 8}

What data supports the effectiveness of the DASH and low-carb diets as treatments for polycystic ovary syndrome?

Research shows that the DASH diet can help improve weight loss and metabolic profiles in women with PCOS, while low-carb diets, including ketogenic diets, may reduce insulin resistance, which is often a problem in PCOS. Both diets have shown benefits in managing symptoms associated with PCOS. ^{3 5 7 9 10}

Who Is on the Research Team?

Laura Saslow, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can do light physical activities.

I can do light physical activities.

You must have a body mass index (BMI) between 25 and 50 if you are not Asian, or between 23 and 50 if you are Asian.

Exclusion Criteria

I have a history of type 1 diabetes.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Baseline testing with a continuous glucose monitor and a body composition scan (DEXA)

1 week

1 visit (in-person)

Treatment

Participants are randomized to a 12-month DASH or very low-carbohydrate diet program with psychological support

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DASH diet
• Very low-carbohydrate diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Very low-carbohydrate diet Experimental Treatment 1 Intervention

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

Group II: DASH diet Active Control 1 Intervention

12-month DASH diet intervention with psychological support

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a 12-week study involving 60 overweight or obese women with PCOS, adherence to the DASH diet led to a significant reduction in body mass index (BMI) and anti-Müllerian hormone (AMH) levels, indicating improvements in weight and hormonal balance.

The DASH diet also improved metabolic profiles by decreasing insulin resistance and free androgen index, while increasing sex hormone-binding globulin and nitric oxide levels, suggesting it may enhance overall metabolic health in women with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of dietary approaches to stop hypertension diet on weight loss, anti-Müllerian hormone and metabolic profiles in women with polycystic ovary syndrome: A randomized clinical trial. Foroozanfard, F., Rafiei, H., Samimi, M., et al.[2018]

In a review of five studies involving 137 women with PCOS, different dietary compositions showed varying effects on outcomes like weight loss, menstrual regularity, and psychological well-being, with a monounsaturated fat-enriched diet leading to greater weight loss and a low-glycemic index diet improving menstrual regularity and quality of life.

Regardless of the specific diet, weight loss was consistently beneficial for managing PCOS symptoms, highlighting the importance of caloric reduction and healthy food choices for overweight women with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary composition in the treatment of polycystic ovary syndrome: a systematic review to inform evidence-based guidelines. Moran, LJ., Ko, H., Misso, M., et al.[2022]

In a study of 48 overweight and obese women with polycystic ovary syndrome (PCOS), following the DASH diet for 8 weeks resulted in significant weight loss and reductions in body mass index compared to a control diet.

The DASH diet also led to improved lipid profiles, including decreased triglycerides and very-low-density lipoprotein cholesterol, as well as increased levels of antioxidants in the body, indicating potential benefits for managing oxidative stress in women with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of DASH diet on lipid profiles and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome: a randomized clinical trial. Asemi, Z., Samimi, M., Tabassi, Z., et al.[2022]

A low-carbohydrate, ketogenic diet (LCKD) significantly improved metabolic and endocrine markers in overweight and obese women with polycystic ovary syndrome (PCOS) over a 24-week period, including a 12% reduction in body weight and a 54% decrease in fasting insulin levels.

Among the five women who completed the study, there were notable reductions in free testosterone and LH/FSH ratio, and two participants achieved pregnancy despite previous infertility issues, suggesting potential reproductive benefits of the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a low-carbohydrate, ketogenic diet on the polycystic ovary syndrome: a pilot study. Mavropoulos, JC., Yancy, WS., Hepburn, J., et al.[2020]

In a 6-month study involving 57 women with polycystic ovary syndrome (PCOS), a high-protein diet led to greater weight loss (average of 4.4 kg) and body fat loss compared to a standard-protein diet, indicating its potential effectiveness in managing PCOS symptoms.

The high-protein diet also resulted in significant improvements in glucose metabolism, suggesting that increasing protein intake may provide metabolic benefits for women with PCOS, independent of weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of increased dietary protein-to-carbohydrate ratios in women with polycystic ovary syndrome. Sørensen, LB., Søe, M., Halkier, KH., et al.[2023]

In a study of 84 obese/overweight women with PCOS, a very-low-calorie ketogenic diet (VLCKD) led to significantly greater reductions in BMI and body circumference compared to a Mediterranean diet (MD) over 120 days.

The VLCKD also resulted in improved metabolic parameters, such as lower HOMA index values and reduced incidence of ovarian hyperstimulation syndrome (OHSS), making it a promising dietary approach for enhancing reproductive health and preparing for IVF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Nutritional Therapy in the Management of Overweight/Obese PCOS Patient Candidates for IVF. Meneghini, C., Bianco, C., Galanti, F., et al.[2023]

Low carbohydrate and ketogenic diets effectively promote weight loss and improve cardiovascular risk markers, such as lowering blood glucose, insulin, and triglycerides, while increasing HDL cholesterol.

These diets can be beneficial for managing obesity, metabolic syndrome, and conditions like polycystic ovary syndrome, but should be supervised by trained professionals to ensure safety and individual suitability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The impact on metabolic and reproductive diseases of low-carbohydrate and ketogenic diets]. Moreno-Sepúlveda, J., Capponi, M.[2021]

The very low-calorie ketogenic diet (VLCKD) was significantly more effective than the Mediterranean low-calorie diet (LCD) in reducing body mass index (BMI) and visceral fat in obese women with polycystic ovary syndrome (PCOS) over a 16-week period, with BMI decreasing by 13.7% in the VLCKD group compared to 5.1% in the LCD group.

The VLCKD also led to a notable improvement in ovulation rates, increasing from 38.5% to 84.6% in the VLCKD group, while the Mediterranean LCD group only increased from 14.3% to 35.7%, highlighting the VLCKD's potential in addressing reproductive issues in PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of very low-calorie ketogenic diet with the Pronokal® method in obese women with polycystic ovary syndrome: a 16-week randomized controlled trial. Pandurevic, S., Mancini, I., Mitselman, D., et al.[2023]

Improving factors like obesity and insulin resistance is crucial in managing Polycystic Ovary Syndrome (PCOS), as these factors are linked to both reproductive and metabolic dysfunction in women.

Dietary changes, such as a low-fat, high-carbohydrate diet or increased protein intake, along with exercise, can significantly help in weight loss and alleviating PCOS symptoms, highlighting the need for effective lifestyle interventions in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and managing disturbances in insulin metabolism and body weight in women with polycystic ovary syndrome. Moran, L., Norman, RJ.[2005]

The DASH eating plan significantly improved insulin resistance and reduced serum hs-CRP levels in overweight and obese women with PCOS after 8 weeks, indicating its potential as an effective dietary intervention for this condition.

Participants following the DASH diet also experienced notable reductions in waist and hip circumference, suggesting additional benefits in abdominal fat loss compared to those on a control diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DASH diet, insulin resistance, and serum hs-CRP in polycystic ovary syndrome: a randomized controlled clinical trial. Asemi, Z., Esmaillzadeh, A.[2015]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The effects of dietary approaches to stop hypertension diet on weight loss, anti-Müllerian hormone and metabolic profiles in women with polycystic ovary syndrome: A randomized clinical trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary composition in the treatment of polycystic ovary syndrome: a systematic review to inform evidence-based guidelines. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of DASH diet on lipid profiles and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome: a randomized clinical trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effects of a low-carbohydrate, ketogenic diet on the polycystic ovary syndrome: a pilot study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of increased dietary protein-to-carbohydrate ratios in women with polycystic ovary syndrome. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Nutritional Therapy in the Management of Overweight/Obese PCOS Patient Candidates for IVF. [2023]

7. Chile pubmed.ncbi.nlm.nih.gov

[The impact on metabolic and reproductive diseases of low-carbohydrate and ketogenic diets]. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of very low-calorie ketogenic diet with the Pronokal® method in obese women with polycystic ovary syndrome: a 16-week randomized controlled trial. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Understanding and managing disturbances in insulin metabolism and body weight in women with polycystic ovary syndrome. [2005]

10. Germany pubmed.ncbi.nlm.nih.gov

DASH diet, insulin resistance, and serum hs-CRP in polycystic ovary syndrome: a randomized controlled clinical trial. [2015]