An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSF Research Institute, Inc.
About this trial
This clinical research study is being conducted to evaluate gut and digestive health before and after the use of a dietary supplement system over an eight-week period.
Gut and digestive health play an important role in overall health, including digestion, nutrient absorption, immune function, and metabolic balance. Changes in gut microbiota, inflammation, and intestinal barrier function may contribute to digestive symptoms such as bloating, discomfort, altered bowel habits, and reduced well-being.
In this study, adult men and women with self-reported gastrointestinal symptoms will consume a dietary supplement system daily for eight weeks. The study will measure changes in gut and digestive health using objective stool-based laboratory biomarkers and validated symptom questionnaires.
Stool samples will be collected at baseline and at the end of the study to evaluate markers related to microbial diversity, inflammation, immune activity, digestive function, and intestinal barrier integrity. Participants will also complete questionnaires throughout the study to assess gastrointestinal symptoms and subjective digestive health and well-being.
The study will also monitor the safety and tolerability of the dietary supplement system during the study period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1. Male or female adults aged 18 to 80 years (considering 50% men and 50% women, even breakdowns in age groups 18-30, 31-60, 61-80 years, and 12-15% African American required) at the time of screening.
Disqualifiers
1. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products.
Malabsorption disorders
Chronic gastrointestinal diseases
Severe depression
Trial design
Design model
Single group
Treatments tested in this trial
PhytoPower 1 and PhytoPower 2
Dietary supplementThe intervention consists of a dietary supplement system comprising two study products, PhytoPower 1 and PhytoPower 2. Participants will be instructed to mix one stick pack of PhytoPower 1 and one stick pack of PhytoPower 2 together in 16 fl. oz. of water and consume the prepared mixture once daily in the morning, with or without food, for a total duration of 8 weeks (56 days). Study products will be dispensed at the Baseline Visit and again at the Week 4 Visit in quantities sufficient to last until the next scheduled visit.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Dietary Supplement GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gut Microbial Diversity
Mean change from baseline to Week 8 in gut microbial diversity assessed using stool-based analysis as part of the Gut Zoomer® test.
Time frame
Baseline (Day 1) to Week 8 (End of Study)2
Mean Change in Stool Calprotectin Concentration from Baseline to Week 8
Mean change from baseline to Week 8 in stool calprotectin concentration, a marker of intestinal inflammation, measured using the Gut Zoomer® test.
Time frame
Baseline (Day 1) to Week 8 (End of Study)3
Mean Change in Stool Beta-Defensin 2 Concentration from Baseline to Week 8
Mean change from baseline to Week 8 in stool beta-defensin 2 concentration, an intestinal immune marker, measured using the Gut Zoomer® test.
Time frame
Baseline (Day 1) to Week 8 (End of Study)4
Mean Change in Stool Secretory Immunoglobulin A (sIgA) Concentration from Baseline to Week 8
Mean change from baseline to Week 8 in stool secretory Immunoglobulin A (sIgA) concentration, an intestinal immune marker, measured using the Gut Zoomer® test.
Time frame
Baseline (Day 1) to Week 8 (End of Study)Secondary outcomes
1
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
To evaluate changes in gastrointestinal symptoms, including abdominal pain, reflux, indigestion, bloating, constipation, and diarrhea, as measured by the validated Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a patient-reported questionnaire using a 7-point Likert scale, with higher scores indicating greater symptom severity.
Time frame
Baseline, Week 2, Week 4, Week 6, and Week 82
Change in Subjective Digestive Health and Well-Being Questionnaire Scores
To assess participant-reported changes in digestive comfort, overall well-being, energy levels, mood, skin health, mental clarity, product tolerability, and user experience using a custom Subjective Digestive Health and Well-Being Questionnaire administered throughout the study.
Time frame
Baseline, Week 2, Week 4, Week 6, and Week 83
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence, severity, and relationship to study product of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported during the 8-week study period.
Time frame
Baseline, Week 2, Week 4, Week 6, and Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SF Research Institute, Inc.
Lead sponsor
Life Vantage
Collaborator
Source ClinicalTrials.gov