An interventional study of Beef+ in PCOS (Polycystic Ovary Syndrome), Obese Adolescents and Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, sponsored by Texas A&M University. Recruiting at 1 site in United States. Open to female participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Texas A&M University · Not applicable, Interventional, and Supportive care
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
Youth-onset Type 2 Diabetes (T2D) is a chronic disease characterized by accelerated beta cell decline and severe insulin resistance (IR). Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a well-established independent risk factor for youth-onset T2D. A first line of treatment for PCOS is lifestyle intervention; however, there is a paucity of evidence evaluating the effectiveness of nutritional strategies in adolescents with PCOS. The overarching goal of the pilot study, termed Beef+, is to replace intake of high fat, processed red meat products with lean beef ("Beef") prepared as part of healthy meals that target increased vegetable and complex carbohydrate intake per the Dietary Guidelines for Americans ("+") and reducing intake of saturated fat, sodium, and added sugar. We will test the hypothesis that incorporating lean beef as part of a healthy meal plan will improve glucoregulation (Aim 1), enhance overall diet quality and satiety (Aim 2), and be a feasible and acceptable dietary intervention strategy that improves participant and household health-related quality of life (Aim 3).
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 36 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Conditional Exclusion Criteria:
- Current use of hormonal if in the suspected PCOS group (allowable if current for at least the previous 3 months with physician-confirmed PCOS)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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.
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
Change in 2-hour Fasting Glucose
Derived from a 75g oral glucose tolerance test (OGTT) as a measure of glycemic variability
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Dropout rate
Drop-out and the reason for drop-out will be recorded, and in both the intervention and usual lifestyle groups will be reported.
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Matsuda Index
Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Insulinogenic Index
Derived from the 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Disposition Index
Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in 2nd Phase Insulin Release
Derived from a 75g oral glucose tolerance test (OGTT), as a measure of insulin sensitivity
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Time in Range
Derived from blinded Continuous Glucose Monitor (CGM) wear, a measure of glycemic variability
Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Continuous Overall Net Glycemic Action (CONGA)
Derived from blinded Continuous Glucose Monitor (CGM) wear, as a metric of glycemic variability
Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Glycemic Risk Assessment in Diabetes Education (GRADE)
Derived from blinded Continuous Glucose Monitor (CGM) wear, measure of glycemic variability
Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Diet Quality - Dietary Recalls
This will be assessed from 24-hour diet recalls and evaluated via Healthy Eating Index (HEI).
Time frame: Baseline and Week 14
Change in Diet Quality - Skin Carotenoids
Skin carotenoids will be measured through the Veggie Meter ®, which uses reflection spectroscopy to estimate skin carotenoid levels. Three scans will be taken on your non-dominant ring finger. After each scan, a dial gauge and a score will appear on the screen. A final score, calculated as the average of the three scans, will range from 0 to 800. Higher scores indicate greater fruit and vegetable intake.
Time frame: Baseline and Week 14
Change in Perceived Hunger
This will be measured through an Appetite/Satiety Questionnaire adapted from commonly used appetite assessment methods and previously applied in dietary intervention research. Participants will report their general appetite and satiety experiences using six items assessing hunger frequency, strength of hunger before meals, fullness after eating, desire to eat when food is available, thoughts about food, and satisfaction after eating. Responses are recorded using a 100-mm visual analogue scale implemented as a 0-100 slider (0 = lowest intensity or frequency; 100 = highest intensity or frequency). Participants will be instructed to move the slider to reflect how strongly each statement describes their typical experience. Data collected will be used to evaluate changes in perceived hunger and fullness throughout the intervention.
Time frame: Baseline and Week 14
Change in incident Pre and Type 2 Diabetes
Type 2 Diabetes is defined as HbA1c \>6.5%.
Time frame: Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle
Compliance- Lean beef intake by self-report
Intake of lean beef, assessed via 24-hour diet recalls
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Compliance - Daily Survey
Intake of lean beef, assessed through daily logs of beef intake by providing portion sized objects that align with serving sizes and ask participants to take photos of their meals with the portion estimator, to ensure that both the meal planning is followed and portion sizes are met.
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Compliance - Blood Biomarkers
Serum hemoglobin will also be assessed as a metric of compliance.
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Participants' Quality of Life
This will be measured through the Pediatric Quality of Life (PedsQL) questionnaire. It includes 23 questions and is scored by reverse-scoring items and linearly transforming them to a 0-100 scale. Higher scores mean better health-related quality of life.
Time frame: Baseline and and Week 14
Household Quality of Life
This will be measured through the Adapted version of the Family Impact Module of the Pediatric Quality of Life (PedsQL). This questionnaire includes 36 questions and includes a 5-point Likert scale (0 to 4), reverse-scored and linearly transformed to a 0-100 scale. Higher scores show better parent health-related quality of life and family functioning with less negative impact.
Time frame: Baseline and Week 14
Exploratory Analysis - Lean Beef
An exploratory analysis will reveal whether lean beef was directly associated with any change in glycemic outcome over time
Time frame: Baseline and Week 14
Economic Evaluation of the Intervention (Ancillary Study, Optional)
An exploratory economic evaluation will estimate household food-related costs associated with participation in the intervention as an ancillary study. Parents or legal guardians will be invited to record and provide receipts for costs related to groceries or food purchased for at-home meal preparation, as well as for meals purchased outside the home, including at restaurants and fast-food venues
Time frame: Baseline and Week 14
Plan to share: No — Individual participant data is not anticipated to be shared on a publicly available database because this is not a federally funded study and given the nature of the data collected and vulnerable population.
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