An interventional study of Food product: high-protein pasta and cereal in Insulin Resistance, sponsored by Arizona State University. Completed. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Arizona State University · Not applicable, Interventional, and Basic science
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 39 is close to the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
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
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
Insulin resistance
Change in insulin resistance
Time frame: 6 weeks
Body composition
Change in body composition
Time frame: 6 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Arizona State University