The goal of this study is to assess the effects of consumption of a lean pork-containing, high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and cardiometabolic parameters in overweight or obese adults with pre-diabetes.
This is a randomized, crossover trial that includes two screening visits, one baseline visit, and two test periods of 2 weeks each, each ending with a test visit, separated by a 2-week washout. Subjects consume each day a refined carbohydrate-rich breakfast containing 8/66/26% kcal from protein/carbohydrate/fat, respectively (Control Condition), or a high pork protein breakfast containing 35/39/26% kcal from protein/carbohydrate/fat, respectively (Active Condition). Study products for daily breakfast consumption will be dispensed to the subjects at the beginning of each test period. Subjects will complete 3-day diet records at baseline and the end of each test period, and a daily Appetite Visual Analog Scale (VAS) Diary to asses perceived hunger and fullness each evening before retiring throughout each test period. VAS assessments of hunger, fullness, desire to eat, prospective food consumption, focus and energy will also be assessed at the clinic visit at the end of each test period, pre- and post-breakfast consumption (multiple time points). Subjects will also complete a palatability questionnaire at the each of each test period. Blood samples will be collected at fasting at baseline and pre- and post-breakfast consumption (multiple sampling) at the end of each test period to evaluate glucose, insulin, and lipoprotein lipid concentrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
22
Refined carbohydrate-rich breakfast containing approximately 8/66/26% kcal from protein/carbohydrate/fat, respectively
High pork protein breakfast containing approximately 35/39/26% kcal from protein/carbohydrate/fat, respectively
Illinois Institute of Technology - Institute for Food Safety and Health
Chicago, Illinois, United States
Net incremental area under the curve (AUC) appetite VAS ratings
Difference between test conditions in net incremental AUC from pre-consumption (t = -15 minutes) to t = 240 minutes for VAS ratings for appetite (fullness, hunger, desire to eat, prospective food consumption)
Time frame: 2 weeks
Net incremental AUC focus and energy VAS ratings
Difference between test conditions in net incremental AUC from pre-consumption (t = -15 minutes) to t = 240 minutes for VAS ratings for focus and energy
Time frame: 2 weeks
Total AUC VAS ratings
Difference between test conditions in total AUC from pre-consumption (t = -15 minutes) to t = 240 minutes for VAS ratings for appetite, focus and energy
Time frame: 2 weeks
Individual time points for VAS ratings
Difference between test conditions in fullness, hunger, desire to eat, prospective food consumption, and focus at individual time points from t = -15 minutes to t = 240 minutes
Time frame: 2 weeks
Energy intake at lunch
Difference between test conditions in the energy intake (kcal) at the lunch meal served at t = 240 minutes at the clinic visit at the end of each test period
Time frame: 2 weeks
Glucose total AUC and incremental AUC
Difference between test conditions in glucose total AUC and incremental AUC from 0 to 120 minutes and 0 to 240 minutes (the t = -15 minutes time point will be counted as t = 0 for this calculation)
Time frame: 2 weeks
Insulin total AUC and incremental AUC
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Difference between test conditions in insulin total AUC and incremental AUC from 0 to 120 minutes and 0 to 240 minutes (the t = -15 minutes time point will be counted as t = 0 for this calculation)
Time frame: 2 weeks
Homeostasis model assessment of insulin sensitivity (HOMA-%S)
Difference between test conditions in HOMA-%S calculated from glucose and insulin values in samples collected at the end of each test period
Time frame: 2 weeks
Homeostasis model assessment of pancreatic beta-cell function (HOMA-%B)
Difference between test conditions in HOMA-%B calculated from glucose and insulin values in samples collected at the end of each test period
Time frame: 2 weeks
Lipoprotein lipids
Difference between test conditions in percent changes from baseline (day 0) to the end of each test condition (days 14 and 42) in triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol
Time frame: 2 weeks
Triglyceride postprandial total AUC and incremental AUC
Difference between test conditions in postprandial total AUC and incremental AUC for triglycerides from 0 to 120 minutes and 0 to 240 minutes (the t = -15 minutes time point will be counted as t = 0 for this calculation)
Time frame: 2 weeks
Composite daily hunger and fullness VAS ratings
Difference between test conditions in the composite hunger and fullness VAS ratings from the daily Appetite VAS Dairy
Time frame: 2 weeks