Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
Purpose
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
- Irregular Menstrual Cycles
- Hirsutism
- Hyperandrogenism
Eligibility
- Eligible Ages
- Between 11 Years and 17 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The statistician is the outcome assessor who is blinded to randomziation.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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+ |
|
Recruiting Locations
College Station, Texas 77843
More Details
- Status
- Recruiting
- Sponsor
- Texas A&M University
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).