Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)

Part of paid clinical trials in College Station, Texas.

Sponsor
Texas A&M University
Study ID
NCT07780188
Status
Recruiting
Apply to this trial

Conditions

  • Hirsutism
  • Hyperandrogenism
  • Irregular Menstrual Cycle
  • Irregular Menstrual Cycles
  • Obese Adolescents
  • Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
  • Overweight Adolescents
  • PCOS (Polycystic Ovary Syndrome)

Eligibility Criteria

Sex
FEMALE
Age
11 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Beef+ — OTHER
    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.

Study Details

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

Key Dates

First listed
Aug 21, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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+

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas A&M AgriLifeCollege StationTexas77843
Heidi Vanden Brink
[email protected]
979--321-7073
Michele Garant, DO (SUB_INVESTIGATOR)
Seung-Yeon "Shawn" Ha, PhD (SUB_INVESTIGATOR)
Lilian Ademu, PhD (SUB_INVESTIGATOR)

Find similar trials in College Station, TX

By research site
Texas A&M AgriLife· College Station, TX

Related Studies