Recruiting

Beef+

Sponsor:

Texas A&M University

Code:

NCT07780188

Conditions

PCOS (Polycystic Ovary Syndrome)

Obese Adolescents

Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities

Overweight Adolescents

Irregular Menstrual Cycle

Eligibility Criteria

Sex: Female

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

Beef+

Study Details

Brief summary:

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

PCOS (Polycystic Ovary Syndrome)

Obese Adolescents

Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities

Overweight Adolescents

Irregular Menstrual Cycle

Study ID

NCT07780188

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 11 - 17

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control/Usual Lifestyle with optional Delayed Intervention

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.

experimental: Beef+

Interventions

Beef+

Adolescents will be instructed to consume a minimum of 1 (3oz) serving per day of cooked unprocessed, lean (<10% fat) beef (21 oz/week) for 12 weeks. To facilitate adoption, the intervention will be offered at the household level, but it is not a requirement. The intervention is a multi-modal behavior change intervention with three overarching components: modifying beef intake, consuming beef in healthy meals, and the research team purchasing the beef needed for the intervention. To facilitate adoption of lean beef as part of a healthy diet, a study RDN will meet with the participant and at least one representative parent/guardian at bi-weekly check-ins to provide tailored dietary support and develop an implementation plan. A financial supplement of $100/month will be provided offset grocery costs.

Primary outcome measure

  • Change in HbA1c [ Time Frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle ]

Central Contacts and Locations

Central contacts

Heidi K Vanden Brink, PhD, MSc, RDMS

979-321-7073heidi.vandenbrink@ag.tamu.edu

Locations

Texas A&M AgriLife

Recruiting

College Station, Texas, United States, 77843

Contacts

More Information

Sponsor

Texas A&M University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Dietary Intervention
  • Polycystic Ovary Syndrome (PCOS)
  • Adolescents
  • Randomized Control Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-13. This information was provided to ClinicalTrials.gov by Texas A&M University on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.