Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Difference in change in body weight between groups over time
研究概览
简要总结
Weight regain following weight loss is common. In rodent models of obesity and pilot studies in humans, increasing membrane arachidonic acid content improves fuel partitioning and prevents weight regain. This study aims to understand the effect of gamma-linolenic acid (GLA) supplementation on weight loss maintenance in Virta Health patients.
详细描述
The primary purpose of this research is to determine if GLA supplementation reduces weight regain over 24 months in Virta Health patients.
The secondary purpose is to determine the effect of GLA supplementation on diabetes-related outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 yrs
- •Patients referred to Virta Health by employers or insurers
- •Weight loss greater than or equal to 7% of initial weight and current BMI > 25 kg/m2
- •Willing to take 3 supplement capsules daily
- •Able to understand study procedures and willing to provide informed consent
- •English-speaking
排除标准
- •Patients who are pregnant or lactating
- •Patients who are taking or are prescribed orlistat
结局指标
主要结局
Difference in change in body weight between groups over time
时间窗: 0, 12, 18, and 24 months
Body weight measured on a calibrated scale. Interim analyses at 12 and 18 months; if greater weight loss is maintained in the GLA compared to placebo group, the study will be unblinded and placebo group participants will cross over to GLA for the remainder of the trial.
次要结局
- Difference in subjective neuropathy symptoms between groups over time(0, 6, 12, 18, and 24 months)
- Difference in perceived control over eating between groups over time(0, 6, 12, 18, and 24 months)
- Difference in health-related quality of life between groups over time(0, 6, 12, 18, and 24 months)
- Difference in body image and satisfaction between groups over time(0, 6, 12, 18, and 24 months)
- Difference in medication prescriptions between groups over time(0, 6, 12, 18, and 24 months)
- Difference in hemoglobin A1c between groups over time(Approximately 0, 6, 12, 18, and 24 months)
- Difference in ketones between groups over time(0, 6, 12, 18, and 24 months)
- Difference in blood glucose between groups over time(0, 6, 12, 18, and 24 months)