Clinical trial · Interventional
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
Effect of Increasing Lean Beef Intake as Part of a Healthy Meal Plan on Glycemic Control in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hirsutism | — | UNRESOLVED | — |
| Hyperandrogenism | — | UNRESOLVED | — |
| Irregular Menstrual Cycle | — | UNRESOLVED | — |
| Irregular Menstrual Cycles | — | UNRESOLVED | — |
| Obese Adolescents | — | UNRESOLVED | — |
| Overweight Adolescents | — | UNRESOLVED | — |
| Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Beef+ | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control/Usual Lifestyle with optional Delayed Intervention
- description
- Participants randomized to usual lifestyle will continue with their usual lifestyle/ diet. Participants will undergo all scheduled study procedures. Upon completion of the 12-week of usual lifestyle, participants randomized to the delayed onset control group will be offered one month of the dietary intervention. The delayed intervention is optional.
- type
- EXPERIMENTAL
- label
- Beef+
- interventionNames
- Other: Beef+
Primary outcomes (1)
- measure
- Change in HbA1c
- timeFrame
- Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
- description
- HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 11 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion 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 Exclusion Criteria: * 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: \- Current use of hormonal contraceptives if in the suspected PCOS group (allowable if current for at least the previous 3 months with physician-confirmed PCOS)
References
Publications (0)
Data not yet available