Overview

This trial is active, not recruiting.

Condition insulin resistance
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
High-protein pasta (orzo and fusilli) enriched with gluten and egg white protein (%energy: 27/30/43 for protein/fat/carbohydrate) and high-protein flaked breakfast cereal enriched with gluten (%energy: 30/35/35 for protein/fat/carbohydrate) were manufactured by Zone Inc.(Boston, MA). The study foods provided an average of 945 kcal/day (one aliquot of cereal and two pasta dishes daily). Pasta meals were prepared in a metabolic kitchen and were identical in appearance and basic taste as control meals.
food product: high-protein pasta and cereal
(Sham Comparator)
Commercial gluten-free pasta (Barcilla orzo and fusilli; %energy: 13/24/63 for protein/fat/carbohydrate) and commercial flaked cereal (Post Honey Bunches of Oats; %energy: 6/18/76 for protein/fat/carbohydrate) were used as the control foods. The study foods provided an average of 945 kcal/day (one aliquot of cereal and two pasta dishes daily). Pasta meals were prepared in a metabolic kitchen and were identical in appearance and basic taste as experimental foods.
food product: high-protein pasta and cereal

Primary Outcomes

Measure
Insulin resistance
time frame: 6 weeks
Body composition
time frame: 6 weeks

Eligibility Criteria

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

Additional Information

Official title Use of Novel High-protein Food Products to Reduce Insulin Resistance in Adults With an Elevated Triglyceride/HDL Ratio
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Arizona State University.