Use of Novel High-protein Food Products To Reduce Insulin Resistance
This trial is active, not recruiting.
|Treatment||food product: high-protein pasta and cereal|
|Sponsor||Arizona State University|
|Collaborator||Inflammation Research Foundation|
|Start date||January 2015|
|End date||December 2015|
|Trial size||39 participants|
|Trial identifier||NCT02851498, ArizonaSU2|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, outcomes assessor)|
|Primary purpose||basic science|
time frame: 6 weeks
time frame: 6 weeks
Male or female participants from 20 years up to 75 years old.
Inclusion Criteria: - 20-75 years of age - BMI 23-42 kg/m2 Exclusion Criteria: - 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
|Official title||Use of Novel High-protein Food Products to Reduce Insulin Resistance in Adults With an Elevated Triglyceride/HDL Ratio|
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