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

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age11-17

SponsorTexas A&M University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female Adolescent

11-17 years old

Suspected or confirmed diagnosis of PCOS

≥1-year post-menarche

Disqualifiers

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%

Trial design

Design model

Parallel

Treatments tested in this trial

Beef+
Other intervention
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.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Control/Usual Lifestyle with optional Delayed InterventionNo intervention 0 interventions

Group B: Beef+Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in HbA1c

HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.

Time frame

Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle