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

NCT02851498 | Completed

• 1 other identifier: ArizonaSU2
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Insulin resistance

  Change in insulin resistance

  6 weeks

• Body composition

  Change in body composition

  6 weeks

Study Arms (2)

Novel high-protein pasta and cereal

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.

Other: Food product: high-protein pasta and cereal

Control 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.

Other: Food product: high-protein pasta and cereal

Interventions

Food product: high-protein pasta and cereal OTHER

Control pasta and cereal; Novel high-protein pasta and cereal

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• BMI 23-42 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Inflammation Research Foundation: collaborator

MeSH Terms

Conditions

Insulin Resistance

Interventions

Edible Grain

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crops, Agricultural; Food; Diet, Food, and Nutrition; Physiological Phenomena; Seeds; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: August 28, 2019

Record last verified: 2019-08