Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures: For Use in Healthy Individuals Ages 18-65 Who Seek to Improve Their Health and Longevity Through Low-dose (Microdosed) GLP1 Receptor Agonists
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Concentration of complete blood cells, as a measure of immunological health, in participants microdosing GLP1s
研究概览
简要总结
The goal of this clinical study has two objectives. The Primary Objective is to evaluate the effectiveness of microdosed GLP-1 receptor agonists in improving measures of health, quality of life, and longevity. The Secondary Objective: To assess the impact of these therapies on weight management practices and metabolic health.
详细描述
Participants will be assigned to one of three groups: 1) control, 2) microdosed sublingual semaglutide, 3) microdosed subcutaneous semaglutide. At baseline and every 4 weeks thereafter, participants will be asked to complete surveys on health, wellness, mood, demographic information, and similar. Additionally, at baseline and every 12 weeks thereafter, they will be requested to complete evaluative blood work to measure CBC, CMP, and standard health biomarker panels (e.g., cholesterol, glucose, creatinine, sodium, potassium). From baseline throughout the duration of the study, participants will be given the option to share data from wearable activity and health trackers with the research team for greater accuracy in evaluating measures of activity, sleep, heart rate, and similar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New or existing AgelessRx patient
- •Adults (aged 18-65)
- •Any ethnicity
- •BMI ≥ 20 kg/m^2
- •Interest in taking microdoses of semaglutide for health and longevity improvement with no intent to seek weight loss improvement.
排除标准
- •Individuals who are denied a longevity product by the AgelessRx medical team will not be asked to participate in any product specific test(s) or questionnaire(s)
- •History of bariatric surgery
- •Use of other weight-loss medications currently or within the past 6 months
- •Contraindications to semaglutide
- •Significant psychiatric illness that may affect participation
- •Pregnant or breastfeeding individuals
研究组 & 干预措施
Oral Placebo
Placebo administered in PCCA sub-magna compounding base only.
干预措施: Placebo (Drug)
Subcutaneous GLP1
Semaglutide 1mg/ml x5ml
干预措施: GLP-1 (Drug)
Sublingual GLP1
Semaglutide 1mg/1ml administered in PCCA sub-magna compounding base only.
干预措施: GLP-1 (Drug)
结局指标
主要结局
Concentration of complete blood cells, as a measure of immunological health, in participants microdosing GLP1s
时间窗: 6 months
CBC panel will be analyzed every 12 weeks over a 24-week period, reported in thousands of cells per microliter with the change from baseline reported as percent deviation and compared to normalized range of healthy individuals
Change in self-reported pain levels in participants microdosing GLP1s
时间窗: 6 months
Participants will complete an extensive medical questionnaire every 4 weeks over a 24-week period to monitor self-reported pain levels
Concentration of basic metabolites (cholesterol, glucose, creatinine, sodium, potassium), as a measure of immunological health, in participants microdosing GLP1s
时间窗: 6 months
BMP panel will be analyzed every 12 weeks over a 24-week period, reported in mg/dL with the change from baseline reported as percent deviation and compared to a normalized range of healthy individuals
Change in heart rate variability in participants microdosing GLP1s
时间窗: 6 months
Participants will wear health devices with data monitored every 4 weeks over a 24-week period to observe change in heart rate variability, being defined as the variability of a participant's resting heart rate. Variability will be measured as an average deviation from baseline heart rate at each timepoint and reported as percent difference.
Changes in sleep patterns in participants microdosing GLP1s
时间窗: 6 months
Wearable health device data will be monitored over the 24-week period assessing REM vs non-REM sleep and reported as a ratio
Change in frequency of physical activity in participants microdosing GLP1s
时间窗: 6 months
The change in frequency of physical activity, defined as a departure from baseline in time spent performing moderate to rigorous physical exercise, will be captured via wearable health device data and will be reported as percent difference from baseline in calories burned.
Change in mood in participants microdosing GLP1s
时间窗: 6 months
Mood will be assessed every 4 weeks over a 24-week period using the SF-36 standardized questionnaire with deviation reported as percent change from baseline
次要结局
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s(6 months)