Clinical Trial Radar

Body Composition

Whole body total, fat, and fat free mass will be determined with Dual X-ray Absorptiometry (DXA). The DXA uses a linear X-ray fan beam with switched-pulse dual-energy and a multi-element detector array. The whole body scan takes \<1.8 sec with radiation exposure of 0.01mGy.

Baseline and 12 weeks

Muscle Mass

D3-creatine method determines muscle mass by measuring the total-body creatine pool size through isotope dilution. Participants will ingest 30 mg of D3-creatine powder dissolved in water. Following consumption, three spot urine samples will be collected at 24-, 48-, and 72-hours using study supplies.

Baseline and 12 weeks

3-day Average Daily Intake

Free-living energy intake, portion sizes, and eating patterns will be assessed using 3 24-h dietary recalls will be collected via a phone intervention or using the computerized ASA24 (Automated Self-administered 24-hour Dietary Assessment Tool) program. The participants will recall everything consumed (beverages and foods) over the previous day.

Baseline and 12 weeks

Energy Expenditure and Sleep

Free-living sleep will be measured for 7 days through actigraphy. The device will be worn continuously on the wrist over a period of 7 days for measures of energy expenditure, resting periods, steps, sleep quality, and latency. Sleep quality and patterns will also be assessed using sleep diaries and questionnaires.

Baseline and 12 weeks

Food Noise

Questionnaires assessing Food Noise will be completed: Food Noise Questionnaire (FNQ) and Ro Allison Dhurandhar Food Noise Inventory (RAID-FN). Higher scores indicate higher presence of food noise.

Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks

Depression

Participants will complete the Patient Health Questionnaire-9 (PHQ-9). 9-item screening tool for depression. Higher scores indicate increased depression severity.

Baseline and 12 weeks

Anxiety

Participants will complete the Generalized Anxiety disorder (GAD) questionnaire which is a 7-item screening tool for generalized anxiety disorder. The questions assess whether various anxiety symptoms have been experienced and how frequently they occurred over a two-week period. Higher scores indicate increased anxiety severity.

Baseline and 12 weeks

Pork Consumption

During a breakfast challenge meal in the laboratory, participants will be provided with specific breakfast foods (i.e., fruit, starchy vegetables, eggs) to consume over a 20 min period. In addition, they will be provided with fresh, minimally processed pork sausage to consume ad libitum during the meal. The pork will be weighed before and after breakfast to assess pork consumption. Questionnaires assessing pork palatability (i.e., appearance, aroma, flavor, texture, overall liking) and appetite/satiety (i.e., hunger, fullness, desire to eat) will collected throughout the breakfast meal. The questionnaires contain VAS incorporating a 100mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."

Baseline and 12 weeks

Appetite, Satiety, Food Craving and Mood

In a free-living environment, participants will be provided with pork breakfast or no pork breakfasts, on separate days. Questionnaires assessing appetitive sensations (i.e., hunger, fullness, desire to eat, prospective food consumption) food cravings (sweet, savory-fat), and mood (sleepy, energy, nauseous) will be collected throughout the day. The questionnaires contain VAS incorporating a 100mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."

Baseline and 12 weeks

Control of Eating

Participants will complete the Control of Eating Questionnaire (CoEQ) which is a 21-item survey that measures severity and type of food cravings an individual experiences over a pre-defined time period.

Baseline and 12 weeks

Health and Well-being Questionnaire

Participants will complete the Short Form 36 Health Survey (SF-36v2) which is a 36-item questionnaire that measures health related quality of life. 8 domains captured: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health that are designed to capture an individual's perceptions on their health and well-being.

Baseline and 12 weeks