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Use of Novel High-protein Food Products To Reduce Insulin Resistance

Use of Novel High-protein Food Products to Reduce Insulin Resistance in Adults With an Elevated Triglyceride/HDL Ratio

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02851498
Enrollment
39
Registered
2016-08-01
Start date
2015-01-31
Completion date
2016-09-30
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

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.

Interventions

OTHERFood product: high-protein pasta and cereal

Sponsors

Inflammation Research Foundation
CollaboratorUNKNOWN
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin resistance6 weeksChange in insulin resistance
Body composition6 weeksChange in body composition

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026