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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which diet—DASH or a very low-carb one—better aids people with polycystic ovary syndrome (PCOS) in managing blood sugar and weight. Participants will follow either the DASH diet (Dietary Approaches to Stop Hypertension diet), known for lowering blood pressure, or a low-carb diet, both combined with psychological support, for 12 months. It suits those with PCOS symptoms, such as irregular periods and elevated male hormones, who can engage in light physical activity and access the internet. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding dietary impacts on PCOS.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the DASH diet and a very low-carbohydrate diet are generally safe and can benefit people with polycystic ovary syndrome (PCOS).

The DASH diet aids in weight loss, improves cholesterol levels, and lowers insulin levels, all crucial for managing PCOS. It also reduces blood pressure, providing an added health benefit. Reports of serious side effects are absent, and most people tolerate it well.

Similarly, the very low-carbohydrate diet promotes weight loss and better blood sugar control. Some studies suggest it might improve fertility for women with PCOS. Like the DASH diet, this low-carb approach does not seem to cause major problems, and people generally manage it well.

Overall, both diets appear safe based on past research. Participants in other studies have found them manageable, with benefits that might help with PCOS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using dietary interventions like the DASH and very low-carbohydrate diets for managing Polycystic Ovary Syndrome (PCOS) because these approaches focus on holistic lifestyle changes rather than medication. Unlike standard treatments that often involve hormonal therapies or insulin-sensitizing drugs, these diets aim to improve metabolic health and support weight management naturally. The DASH diet emphasizes heart-healthy food choices, which may reduce inflammation, while the very low-carbohydrate diet could enhance insulin sensitivity by minimizing carb intake. By incorporating psychological support, these diets also address the mental and emotional challenges associated with PCOS, offering a comprehensive approach to treatment.

What evidence suggests that this trial's treatments could be effective for polycystic ovary syndrome?

This trial will compare the DASH diet with a very low-carbohydrate diet for managing polycystic ovary syndrome (PCOS). Research has shown that the DASH diet aids in weight loss and better blood sugar control, improving insulin handling, which is crucial for managing PCOS symptoms. Meanwhile, a very low-carbohydrate diet has demonstrated promising results for PCOS, assisting with weight loss and body shape, and positively affecting hormone levels. Some studies suggest that women with PCOS who follow this diet may have higher chances of pregnancy. Both diets offer potential benefits and are worth considering for managing PCOS symptoms. ^{1 6 7 8 9}

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

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]

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 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]

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]

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 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 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]

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 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]

Citations

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Protocol for a randomized comparative effectiveness trial ... This research investigates whether a very low-carbohydrate diet is more effective in improving glucose control and decreasing symptoms of PCOS in comparison to ...

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Ranking the dietary interventions by their effectiveness in ... Based on our results, the DASH diet is the most effective dietary intervention for treating PCOS. Registration PROSPERO ID CRD42021282984.

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Protocol for a randomized comparative effectiveness trial ... This research investigates whether a very low-carbohydrate diet is more effective in improving glucose control and decreasing symptoms of PCOS ...

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The effects of dietary approaches to stop hypertension diet ... Adherence to the DASH diet for 12 weeks among PCOS women had beneficial effects on BMI, AMH, insulin metabolism, SHBG, FAI, NO and MDA levels.

5. mdpi.com mdpi.com/2072-6643/17/4/674

The Influence of Dietary Patterns on Polycystic Ovary ... In conclusion, the DASH diet appeared to be effective in BW and glucose control in women with PCOS using an isocaloric dietary design. 3.1.2. Ketogenic Diet.

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Protocol for a randomized comparative effectiveness trial ... This research investigates whether a very low-carbohydrate diet is more effective in improving glucose control and decreasing symptoms of PCOS in comparison to ...

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Effects of Dietary Approach to Stop Hypertension diet on ... The DASH diet could improve weight loss, BMI and fat mass. Furthermore, it could result in a significant reduction in serum androstenedione and a ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S093947532500211X

Effect of Dietary Approaches to Stop Hypertension (DASH ... DASH diet significantly reduced total cholesterol, LDL-C and VLDL-C levels. · Greater reductions were observed in ≤8 weeks of interventions. · All of the included ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25194966/

Effects of DASH diet on lipid profiles and biomarkers ... Conclusion: Consumption of DASH diet for 8 wk led to a significant reduction in serum insulin, triglycerides and very-low-density lipoprotein cholesterol and a ...