Clinical trial for PCOS (Polycystic Ovary Syndrome)
Official title Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
ClinicalTrials.gov ID: NCT07780188
What this study is testing
- What it's testing
- This pilot randomized controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to evaluate the effectiveness and feasibility of a tailored dietary intervention which will be termed "Beef+", that will emphasize the incorporation of unprocessed, lean beef (\<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 17, women only
You may be able to join if
- Female Adolescent
- 11-17 years old
- Suspected or confirmed diagnosis of PCOS
- ≥1-year post-menarche
- BMI ≥85th percentile for age/height
You likely can't join if
- Medications affecting glucoregulation, metabolic health, and/or appetite (e.g., metformin, GLP-1)
- Unable or unwilling to eat beef
- Pregnant or planning pregnancy during study
- HbA1c ≥6.5%
- Unwilling or unable to complete study procedures
- Conditions affecting ability to complete study procedures or the intervention such as gastrointestinal diseases or syndromes, bleeding disorders...
See the full eligibility criteria
- Female Adolescent
- 11-17 years old
- Suspected or confirmed diagnosis of PCOS
- ≥1-year post-menarche
- BMI ≥85th percentile for age/height
- Able to read and speak English
- Medications affecting glucoregulation, metabolic health, and/or appetite (e.g., metformin, GLP-1)
- Unable or unwilling to eat beef
- Pregnant or planning pregnancy during study
- HbA1c ≥6.5%
- Unwilling or unable to complete study procedures
- Conditions affecting ability to complete study procedures or the intervention such as gastrointestinal diseases or syndromes, bleeding disorders, ongoing or unresolved eating disorder)
- Conditions affecting reproductive function other than PCOS
- Conditions that may interfere with continuous glucose monitor (CGM) application or use, including dermatological conditions such as eczema or allergies/reactions to medical adhesives Conditional Exclusion Criteria: \-...
The study team makes the final eligibility decision.
Where it's taking place
- College Station, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 11 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include College Station, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.