Hirsutism, Hyperandrogenism, Irregular Menstrual Cycle, Irregular Menstrual Cycles, Obese Adolescents, Overweight Adolescents, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, PCOS (Polycystic Ovary Syndrome)
Conditions
Keywords
Dietary Intervention, Polycystic Ovary Syndrome (PCOS), Adolescents, Randomized Control Trial
Brief 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 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).
Interventions
OTHERBeef+
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.
Sponsors
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician is the outcome assessor who is blinded to randomziation.
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 2-hour Fasting Glucose | Baseline and Week 12 of Intervention or Usual Lifestyle | Derived from a 75g oral glucose tolerance test (OGTT) as a measure of glycemic variability |
| Dropout rate | Baseline and Week 12 of Intervention or Usual Lifestyle | Drop-out and the reason for drop-out will be recorded, and in both the intervention and usual lifestyle groups will be reported. |
| Change in Matsuda Index | Baseline and Week 12 of Intervention or Usual Lifestyle | Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity |
| Change in Insulinogenic Index | Baseline and Week 12 of Intervention or Usual Lifestyle | Derived from the 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity |
| Change in Disposition Index | Baseline and Week 12 of Intervention or Usual Lifestyle | Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity |
| Change in 2nd Phase Insulin Release | Baseline and Week 12 of Intervention or Usual Lifestyle | Derived from a 75g oral glucose tolerance test (OGTT), as a measure of insulin sensitivity |
| Change in Time in Range | Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle | Derived from blinded Continuous Glucose Monitor (CGM) wear, a measure of glycemic variability |
| Change in Continuous Overall Net Glycemic Action (CONGA) | Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle | Derived from blinded Continuous Glucose Monitor (CGM) wear, as a metric of glycemic variability |
| Change in Glycemic Risk Assessment in Diabetes Education (GRADE) | Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle | Derived from blinded Continuous Glucose Monitor (CGM) wear, measure of glycemic variability |
| Change in Diet Quality - Dietary Recalls | Baseline and Week 14 | This will be assessed from 24-hour diet recalls and evaluated via Healthy Eating Index (HEI). |
| Change in Diet Quality - Skin Carotenoids | Baseline and Week 14 | 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. |
| Change in Perceived Hunger | Baseline and Week 14 | 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. |
| Change in incident Pre and Type 2 Diabetes | Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle | Type 2 Diabetes is defined as HbA1c \>6.5%. |
Countries
United States
Contacts
CONTACTHeidi K Vanden Brink, PhD, MSc, RDMS
PRINCIPAL_INVESTIGATORHeidi K Vanden Brink, PhD, MSc, RDMS
Texas A&M University
Outcome results
None listed