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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-12 months
Awards & highlights
SUPER Trial Summary
This trial will test whether a DASH or low-carb diet is better for improving blood sugar control and weight for adults with polycystic ovary syndrome.
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.Check my eligibility
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.See study design
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.
SUPER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My periods are irregular, occurring less than 8 times a year or not within 21-35 days.
Select...
My hormone levels and hair growth match the study's requirements.
Select...
I have irregular or no menstrual periods.
SUPER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in HbA1c
Change in glycemic variability
Change in percent body fat on DEXA
+1 moreSUPER 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
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,890 Total Patients Enrolled
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,772 Total Patients Enrolled
Laura Saslow, PhDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
524 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of type 1 diabetes.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.I am not on any glucose-lowering medications except for metformin.My irregular periods and high male hormone levels are not due to PCOS.I am unable to understand and give consent for treatment.Your HbA1c level at the start of the study should be between 5.3% and 9.0%.I have a blood disorder that affects my HbA1c levels.I have had or plan to have weight-loss surgery.My periods are irregular, occurring less than 8 times a year or not within 21-35 days.I have had irregular periods while using hormonal birth control.I cannot read, write, or speak English.You have reported having problems with alcohol or drugs in the last 5 years.I am not currently in another weight loss program.I am willing to follow any assigned diet plan.I am open to trying either of the diet plans offered in the study.I am taking medication for weight loss or psychostimulants.I do not have severe kidney disease, untreated eating disorders, serious mental health issues, or use warfarin.You weigh more than 500 pounds and cannot undergo DEXA scans.I have trouble chewing or swallowing.Participants must have high levels of male hormones.I have gone through menopause or had my ovaries removed.My hormone levels and hair growth match the study's requirements.You follow a vegan or vegetarian diet.You cannot control what food you eat or cannot follow dietary advice because you don't have enough money or resources.I have irregular or no menstrual periods.
Research Study Groups:
This trial has the following groups:- Group 1: DASH diet
- Group 2: Very low-carbohydrate diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals can partake in this research?
"Affirmative, the information posted on clinicaltrials.gov shows that this research is actively enrolling participants at present time. The study was initialised on August 15th 2022 and last updated September 18th 2022 with a recruitment goal of 184 patients across one location."
Answered by AI
Are any octogenarians being included in this experiment?
"The age range for this clinical trial is between 21 and 40, as specified by the eligibility requirements."
Answered by AI
Is this study still accepting participant enrolment?
"Absolutely, the information hosted on clinicaltrials.gov affirms that this trial is actively recruiting patients for participation. The study was initially posted to the website on August 15th 2022 and underwent its last update on September 18th of the same year. 184 persons are required from a single site in order to complete enrollment goals."
Answered by AI
What are the eligibility requirements to participate in this clinical investigation?
"This medical investigation is seeking 184 individuals aged between 21 and 40 who are suffering from sclerocystic ovaries. To be considered, applicants must demonstrate oligomenorrhea-anovulation, a history of irregular menses, hyperandrogenism as evidenced by elevated testosterone/free testosterone/free androgen index or hirsutism (as judged in person if not on hormonal birth control), low 17-hydroxyprogesterone levels, suppressed prolactin concentrations, intermenstrual periods that fall below the threshold for spontaneity - either <21 days or >35 days with no more than 8 menstrual cycles per"
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
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