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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insulin Resistance

Intervention / Treatment
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* Other: Food product: high-protein pasta and cereal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel high-protein pasta and cereal<br>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<br> <br> |
| Sham Comparator: Control pasta and cereal<br>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<br> <br> |

What is the study measuring?
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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 |