Use of Novel High-protein Food Products to Reduce Insulin Resistance in Adults With an Elevated Triglyceride/HDL Ratio
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Insulin resistance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-75 years of age
- •BMI 23-42 kg/m2
排除标准
- •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
研究组 & 干预措施
Novel high-protein pasta and cereal
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.
干预措施: Food product: high-protein pasta and cereal (Other)
Control 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.
干预措施: Food product: high-protein pasta and cereal (Other)
结局指标
主要结局
Insulin resistance
时间窗: 6 weeks
Change in insulin resistance
Body composition
时间窗: 6 weeks
Change in body composition
次要结局
未报告次要终点
研究者
Carol Johnston
Professor
Arizona State University