An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System

NCT07421596 | Recruiting

• 1 other identifier: LV-GUT-CT-01-26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Symptoms; Digestive Health; Gut Health

Keywords

Stool biomarkers; Probiotics; Subjective digestive health; Gut Zoomer stool test

Outcome Measures

Primary Outcomes (11)

• 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.

  Baseline (Day 1) to Week 8 (End of Study)

• 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.

  Baseline (Day 1) to Week 8 (End of Study)

• 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.

  Baseline (Day 1) to Week 8 (End of Study)

• 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.

  Baseline (Day 1) to Week 8 (End of Study)

• Change in Digestive Function Biomarkers

  Mean change from baseline to Week 8 in digestive health biomarkers (short-chain fatty acids) assessed using stool-based analysis.

  Baseline (Day 1) to Week 8 (End of Study)

• Mean Change in Stool Bile Acid Concentration From Baseline to Week 8

  Mean change from baseline to Week 8 in stool bile acid concentration assessed using stool-based analysis.

  Baseline (Day 1) to Week 8 (End of Study)

• Mean Change in Stool Malabsorption Marker Concentration From Baseline to Week 8

  Mean change from baseline to Week 8 in stool-based markers of malabsorption assessed using stool-based analysis.

  Baseline (Day 1) to Week 8 (End of Study)

• Mean Change in Stool Lipopolysaccharide (LPS) Concentration From Baseline to Week 8

  Mean change from baseline to Week 8 in stool lipopolysaccharide (LPS) concentration assessed using stool-based analysis.

  Baseline (Day 1) to Week 8 (End of Study)

• Mean Change in Stool Zonulin Concentration From Baseline to Week 8

  Mean change from baseline to Week 8 in stool zonulin concentration assessed using stool-based analysis.

  Baseline (Day 1) to Week 8 (End of Study)

• Mean Change in Stool Tissue Transglutaminase (tTG) Concentration From Baseline to Week 8

  Mean change from baseline to Week 8 in stool tissue transglutaminase (tTG) concentration assessed using stool-based analysis.

  Baseline (Day 1) to Week 8 (End of Study)

• Mean Change in Stool Anti-Gliadin Antibody Concentration From Baseline to Week 8

  Mean change from baseline to Week 8 in stool anti-gliadin antibody concentration assessed using stool-based analysis.

  Baseline (Day 1) to Week 8 (End of Study)

Secondary Outcomes (3)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) Score

  Baseline, Week 2, Week 4, Week 6, and Week 8

• Change in Subjective Digestive Health and Well-Being Questionnaire Scores

  Baseline, Week 2, Week 4, Week 6, and Week 8

• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Baseline, Week 2, Week 4, Week 6, and Week 8

Study Arms (1)

Dietary Supplement Group

EXPERIMENTAL

Participants in this single-arm study will receive a dietary supplement system consisting of two study products, PhytoPower 1 and PhytoPower 2, administered once daily for 8 weeks. Participants will be instructed to mix one stick pack of PhytoPower 1 and one stick pack of PhytoPower 2 into 16 fl. oz. of water and consume the prepared mixture every morning, with or without food. The study will evaluate changes in gut and digestive health parameters using stool-based biomarkers and validated gastrointestinal symptom questionnaires over the study period.

Dietary Supplement: PhytoPower 1 and PhytoPower 2

Interventions

PhytoPower 1 and PhytoPower 2 DIETARY_SUPPLEMENT

The 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.

Dietary Supplement Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Willing and able to provide written informed consent before participation in any study-related procedures.
• \. Willing and able to comply with all study procedures, including clinic visits, completion of questionnaires, and stool sample collection at predetermined time points.
• \. Willing to collect and provide stool samples, either in-clinic or at home as instructed.
• \. Willing to abstain from alcohol consumption (including beer, wine, and spirits) for the duration of the study.
• \. Proficient in written and spoken English. 7. Willing to provide a valid email address and mobile phone number and able to complete electronic forms and questionnaires using a smartphone.
• \. Able and willing to travel to the Research Institute for in-clinic visits and stool sample collection as scheduled.
• \. No known food allergies, based on subject self-report. 10. Willing to maintain usual diet and lifestyle habits, except as required by the study protocol.
• \. Subjects with self-reported gastrointestinal symptoms, defined as a baseline Gastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 subjects) and score ≤ 3 (5 subjects).

You may not qualify if:

• \. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products.
• \. Presence or history of any medical condition that may interfere with study participation or outcome interpretation, including but not limited to:
• Malabsorption disorders
• Chronic gastrointestinal diseases
• Severe depression
• Clinically significant cardiovascular disease within the past 3 months 3. Pregnant, breastfeeding, or planning to become pregnant during the study period, based on subject self-report.
• \. Having a pregnant partner or a partner who is planning to become pregnant during the study period and is unwilling or unable to use an acceptable method of contraception.
• \. History of any cancer within the past 5 years. 6. Active or occasional smoking. 7. Current use of probiotics, unless willing to discontinue use at least 4 weeks prior to study enrollment.
• \. History of weight loss surgery or any type of bowel surgery, including resection or colectomy.
• \. Any active infection within the past 3 months requiring antibiotics, antiviral medication, or hospitalization.
• \. Use of immunosuppressive medications within the past 12 months, including systemic corticosteroids or biologic agents.
• \. History of seizure disorder or use of seizure medication within the past 4 weeks.
• \. History of HIV infection or solid organ transplantation. 13. Use of medications for chronic gastrointestinal or digestive conditions, including but not limited to:
• Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®)
• Laxatives or gastrointestinal motility agents

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Life Vantage: collaborator

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

RECRUITING

Central Study Contacts

Dr. John Ademola

CONTACT

415-845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. All participants, investigators, and study staff are aware of the study intervention being administered.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a prospective, open-label, single-arm clinical study designed to evaluate changes in gut and digestive health parameters following daily use of a dietary supplement system over an 8-week period. All enrolled participants will receive the same study intervention and will be followed according to a predefined visit schedule.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 5, 2026
• Primary Completion: April 6, 2026
• Study Completion: April 21, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)