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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851498
• Other study ID #: ArizonaSU2
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• Food product: high-protein pasta and cereal

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Inflammation Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	Change in insulin resistance	6 weeks
Primary	Body composition	Change in body composition	6 weeks