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

NCT ID: NCT02851498

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Food product: high-protein pasta and cereal

Intervention Type: OTHER

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.

Group Type: SHAM_COMPARATOR

Food product: high-protein pasta and cereal

Intervention Type: OTHER

Interventions

Food product: high-protein pasta and cereal

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inflammation Research Foundation

UNKNOWN

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Carol Johnston

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ArizonaSU2

Identifier Type: -

Identifier Source: org_study_id