GLOW Study: A Randomized Trial to Evaluate the Effects of Triple Support Protein on Glucose, Lifestyle, and Overall Well-being in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in postprandial glucose area under the curve (AUC)
研究概览
简要总结
This single-site, randomized, blinded, placebo-controlled study will evaluate whether 4 weeks of daily Triple Support Protein powder improves glycemic control and overall well-being in healthy women aged 30-60 years. Participants will undergo baseline testing (DXA, fasting blood, standardized meal test with 2-hour glucose and insulin sampling), complete one acute supervised dose, and then consume a daily supplement for 4 weeks. During the final 14 days, participants will wear a continuous glucose monitor. Outcomes include postprandial glucose AUC, insulin sensitivity, and body composition.
详细描述
Midlife women experience hormonal changes that can impair metabolic health, sleep, and cognition. Triple plant-based protein powder includes creatine and fiber aimed at glycemic control, muscle support, and satiety. Design: 40 participants randomized (1:1) to Triple Protein Support vs. matched placebo for 4 weeks, with acute and chronic phases, weekly check-ins. Assessments: Baseline and end-of-study DXA and bloods; standardized meal tests with 2-hour glucose/insulin sampling; Analysis: Mixed-model ANOVA for primary and secondary endpoints with α=0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 30-60 years.
- •BMI 18.5-40 kg/m^
- •Recreationally active (≥30 min/wk moderate intensity exercise).
- •Healthy and free from disease per health history questionnaire.
- •Willing to abstain from caffeine, tobacco, and alcohol for 24 hours before testing days.
排除标准
- •Currently supplementing whey protein.
- •Pregnant or nursing.
- •Lactose intolerant.
- •Currently using creatine monohydrate.
- •Severe hearing or speech impairment or inability to speak English
研究组 & 干预措施
Triple Protein Support
Daily one serving of plant-based protein + creatine + fiber mixed with 8-12 fl oz water for 4 weeks
干预措施: Triple protein support (Dietary Supplement)
Placebo
Daily one serving of a non-caloric, texture- and weight-matched placebo for 4 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in postprandial glucose area under the curve (AUC)
时间窗: Glucose measured over 0-120 minutes starting post standardized meal
Glucose measured at 0-120 minutes post-meal; AUC by trapezoidal method.
次要结局
- Change in insulin sensitivity (HOMA-IR)(Baseline, Week 6)
- Change in lean soft tissue(Baseline, week 6)