PCOS (Polycystic Ovary Syndrome)Beef+NCT07780188
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
A study testing Beef+ in people with PCOS (Polycystic Ovary Syndrome) and Obese Adolescents, run by Texas A&M University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 17 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome), Obese Adolescents, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
- What is being tested?
- Beef+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas A&M AgriLife
College Station, Texas, 77843
Heidi Vanden Brink, 979--321-7073, heidi.vandenbrink@ag.tamu.edu
Michele Garant, DO
About this study
Official title: 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)
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
Read the detailed description
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).
- Conditions
- PCOS (Polycystic Ovary Syndrome), Obese Adolescents, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight Adolescents, Irregular Menstrual Cycle, Irregular Menstrual Cycles
- Being tested
- Beef+
- Keywords
- Dietary Intervention, Polycystic Ovary Syndrome (PCOS), Adolescents, Randomized Control Trial
- Medical subject headings
- Polycystic Ovary Syndrome, Overweight, Menstruation Disturbances, Hirsutism, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Control/Usual Lifestyle with optional Delayed Intervention | No 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. |
| Beef+ | Experimental | Not described Receives: Other: Beef+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.
Measured: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Secondary outcomes (13)
Change in 2-hour Fasting Glucose
Derived from a 75g oral glucose tolerance test (OGTT) as a measure of glycemic variability
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and Week 14
Change in incident Pre and Type 2 Diabetes
Type 2 Diabetes is defined as HbA1c >6.5%.
Measured: Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Vanden Brink, Texas A&M University
- Investigators
- Heidi K Vanden Brink, PhD, MSc, RDMS, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780188
- Sponsor's protocol ID
- IRB#STUDY2026-0483
- Other IDs
- #2681, Lab Research Funds
- Acronym
- Beef+
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07780188
- Acronym / sponsor ID
- Beef+ / IRB#STUDY2026-0483
- Conditions
- PCOS (Polycystic Ovary Syndrome), Obese Adolescents, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight Adolescents, Irregular Menstrual Cycle, Irregular Menstrual Cycles
- Keywords
- Dietary Intervention, Polycystic Ovary Syndrome (PCOS), Adolescents, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control/Usual Lifestyle with optional Delayed Intervention | No 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. |
| Beef+ | Experimental | Other: Beef+ |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Female Adolescent
- 11-17 years old
- Suspected or confirmed diagnosis of PCOS
- ≥1-year post-menarche
- BMI ≥85th percentile for age/height
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Beef+ |
Primary outcome
Change in HbA1c
Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.
13 secondary outcomes
Change in 2-hour Fasting Glucose
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Dropout rate
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Matsuda Index
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Insulinogenic Index
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Disposition Index
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in 2nd Phase Insulin Release
Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Time in Range
Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Continuous Overall Net Glycemic Action (CONGA)
Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Glycemic Risk Assessment in Diabetes Education (GRADE)
Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Diet Quality - Dietary Recalls
Time frame: Baseline and Week 14
Change in Diet Quality - Skin Carotenoids
Time frame: Baseline and Week 14
Change in Perceived Hunger
Time frame: Baseline and Week 14
Change in incident Pre and Type 2 Diabetes
Time frame: Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for PCOS (Polycystic Ovary Syndrome)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heidi K Vanden Brink, PhD, MSc, RDMS principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beef+ in people with PCOS (Polycystic Ovary Syndrome) and Obese Adolescents, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi K Vanden Brink, PhD, MSc, RDMS (979-321-7073, heidi.vandenbrink@ag.tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.