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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Other: Food product: high-protein pasta and cereal

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel high-protein pasta and cereal; 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.	Other: Food product: high-protein pasta and cereal
Sham Comparator: Control pasta and cereal; 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.	Other: Food product: high-protein pasta and cereal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin resistance	Change in insulin resistance	6 weeks
Body composition	Change in body composition	6 weeks

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Inflammation Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: ArizonaSU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED