Abdominal Bloating, Abdominal Pain, Digestive Health, Energy Levels, Fatigue, Liver Health, Nausea
Conditions
Brief summary
This study will evaluate the effects of Edenboost Alpha Cleanse, a dietary supplement, on symptoms associated with liver and digestive health. The study is a single-arm, open-label trial in which all 40 enrolled participants will use the test product daily for 12 weeks. Participants will complete questionnaires at Baseline, Week 4, Week 8, and Week 12, and will undergo blood testing (hepatic function panel) at Baseline and Week 12. Primary outcomes focus on changes in liver function biomarkers, while secondary outcomes capture participants' self-reported experiences of energy levels, abdominal bloating, abdominal pain, fatigue, and nausea.
Interventions
DIETARY_SUPPLEMENTEdenboost Alpha Cleanse
All participants receive Edenboost Alpha Cleanse (two capsules once daily with the first meal of the day) for 12 weeks.
Sponsors
Edenboost
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Be male or female. * Be aged 40-65. * Anyone who has struggled with low energy levels and fatigue over the past four weeks. * Anyone who has struggled with at least two of the following symptoms over the past four weeks: abdominal bloating, abdominal discomfort, constipation, diarrhea, digestive discomfort. * Willing to maintain the same diet, sleep pattern, and exercise regimen consistently throughout the study duration. * If taking any other supplements, medications, or herbal remedies, has been doing so consistently for at least three months and is willing to maintain this routine for the duration of the trial. * Willing to avoid introducing any other supplements, medications, or herbal remedies for the duration of the trial. * Resides in the United States.
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including mental health disorders, a history of serious illness in the last three months, a history of substance abuse, or planned surgery during the study period. * Anyone with a known history of severe digestive disorders like acid reflux, peptic ulcers, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), GI bleeding, Crohn's disease, Ulcerative Colitis (UC), or gastrointestinal tract surgeries. * Anyone with a history of kidney stones. * Anyone with any allergies or sensitivities to any of the study product ingredients. * Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period). * Anyone on Coumadin (warfarin) or antiplatelet therapy (e.g., Plavix (clopidogrel), aspirin). * Anyone with uncontrolled chronic disease, including but not limited to diabetes, hypertension (high blood pressure), and thyroid-related conditions. * Anyone unwilling to follow the study protocol. * Anyone who is currently a smoker or has been a smoker in the past 3 months. * Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alanine Aminotransferase (ALT/SGPT) | Baseline and Week 12 | Change in serum ALT/SGPT level assessed via hepatic function panel blood test at Labcorp |
| Change in Albumin | Baseline and Week 12 | Change in serum albumin level assessed via hepatic function panel blood test at Labcorp |
| Change in Alkaline Phosphatase | Baseline and Week 12 | Change in serum alkaline phosphatase level assessed via hepatic function panel blood test at Labcorp |
| Change in Aspartate Aminotransferase (AST/SGOT) | Baseline and Week 12 | Change in serum AST/SGOT level assessed via hepatic function panel blood test at Labcorp |
| Change in Bilirubin | Baseline and Week 12 | Change in serum bilirubin level assessed via hepatic function panel blood test at Labcorp |
| Change in Total Protein | Baseline and Week 12 | Change in serum total protein level assessed via hepatic function panel blood test at Labcorp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Abdominal Bloating | Baseline, Week 4, Week 8, and Week 12 | Participant-reported change in abdominal bloating assessed via self-reported questionnaire |
| Change in Self-Reported Abdominal Pain | Baseline, Week 4, Week 8, and Week 12 | Participant-reported change in abdominal pain assessed via self-reported questionnaire |
| Change in Self-Reported Fatigue | Baseline, Week 4, Week 8, and Week 12 | Participant-reported change in fatigue assessed via self-reported questionnaire |
| Change in Self-Reported Nausea | Baseline, Week 4, Week 8, and Week 12 | Participant-reported change in nausea assessed via self-reported questionnaire |
| Change in Self-Reported Energy Levels | Baseline, Week 4, Week 8, and Week 12 | Participant-reported change in energy levels assessed via self-reported questionnaire |
Countries
United States
Outcome results
None listed