Use of Novel High-protein Food Products To Reduce Insulin Resistance
- Conditions
- Insulin Resistance
- Registration Number
- NCT02851498
- Lead Sponsor
- Arizona State University
- Brief Summary
This controlled weight loss trial in adults at cardiometabolic risk (elevated triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel, high-protein pasta and cereal to examine the physiological impact of stealth substitution of dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM cereal) was matched with conventional flaked cereal. Participants were instructed to follow an energy restricted diet (-500 kcal/d) and incorporate a test food into each of three meals over a 24-hour period. The diet-induced changes in body mass and lean body mass were tracked as well as changes in in insulin sensitivity and common blood biomarkers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 20-75 years of age
- BMI 23-42 kg/m2
- food allergies
- diet restrictions (e.g., vegetarian, gluten or lactose intolerant)
- insulin use
- cigarette use
- active disease states including diagnosed diabetes
- anticipated changes to diet or physical activity levels
- recent weight gain or loss (±10 pounds)
- current or recent pregnancy or lactation
- prescription medication use by participants was allowed if use had been consistent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Insulin resistance 6 weeks Change in insulin resistance
Body composition 6 weeks Change in body composition
- Secondary Outcome Measures
Name Time Method