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OpenTrials
Completed

NCT Number: NCT02851498

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

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food product: high-protein pasta and cereal

Other

Primary outcomes

  1. Insulin resistance

    Time frame: 6 weeks

    Change in insulin resistance

  2. Body composition

    Time frame: 6 weeks

    Change in body composition

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Inflammation Research Foundation

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 1, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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