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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
36
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.
Texas A&M AgriLife
College Station, Texas, United States
RECRUITINGChange 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
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