Alertness, Immune Health, Inflammation, Longevity, Mood, Pain Management, Quality of Life, Weight Management
Conditions
Keywords
Microdosing GLP1s, Longevity, Weight Management, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
DRUGGLP-1
Sublingual GLP1 (weekly), Subcutaneous GLP1 (weekly), Sublingual Placebo (weekly) for up to 6 months.
DRUGPlacebo
Sublingual Placebo (weekly) for up to 6 months
Sponsors
AgelessRx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Single-Center, Prospective, Blinded, Randomised, Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* New or existing AgelessRx patient * Adults (aged 18-65) * Any sex * 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of physical activity in participants microdosing GLP1s | 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 steps taken. |
| Change in self-reported pain levels in participants microdosing GLP1s | 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 complete blood cells, as a measure of immunological health, in participants microdosing GLP1s | 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 |
| Concentration of basic metabolites (cholesterol, glucose, creatinine, sodium, potassium), as a measure of immunological health, in participants microdosing GLP1s | 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 mood in participants microdosing GLP1s | 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 |
| Change in heart rate variability in participants microdosing GLP1s | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s | 6 months | Changes in HbA1c levels will be assessed every 12 weeks and reported as a percent deviation from baseline |
Countries
United States
Outcome results
None listed