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CompletedNCT07898189Updated Oct 27, 2026

A Study to Evaluate the Effects of a Supplement on Gut Comfort in GLP-1 Receptor Agonist Users

An interventional study of Placebo and Oxxynea® Supplement in Gastrointestinal Discomfort, Gastrointestinal Side Effects of GLP-1 Receptor Agonist Use and Nausea, sponsored by AB Mauri (UK) Limited,. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by AB Mauri (UK) Limited, · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2026, registered Oct 2026).
Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a randomized, triple-blind, placebo-controlled, virtual clinical trial evaluating the effects of the Oxxynea® botanical supplement on gut comfort in adults who use GLP-1 receptor agonists (GLP-1 RAs). Seventy participants experiencing gastrointestinal discomfort associated with GLP-1 RA use will be randomized to receive either Oxxynea® or a matching placebo once daily for six weeks.

Participants will complete questionnaires at Baseline, daily for the first 14 days, and at the end of Weeks 2, 4, and 6. The primary measure is change in gastrointestinal comfort assessed by the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures include quality of life, participant-perceived product benefits, and specific GI symptom changes (nausea, abdominal pain, bloating, diarrhea, and constipation).

02

Conditions studied

  • Gastrointestinal Discomfort
  • Gastrointestinal Side Effects of GLP-1 Receptor Agonist Use
  • Nausea
  • Abdominal Pain
  • Bloating
  • Diarrhea
  • Constipation
03

In context

Nausea

644 studies on the registry are indexed under Nausea; 85 are open to participants now.

This study's enrollment of 70 is below the median of 96 across 544 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

This is the only study on the registry with AB Mauri (UK) Limited, as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be male or female.
  • Be aged 18-65.
  • ≥ 27.
  • Anyone currently taking a GLP-1-based therapy, including GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists.
  • Anyone experiencing issues regarding at least two of the following symptoms since starting a GLP-1 receptor agonist medication, at a frequency of at least 2-3 times per week: gut discomfort, diarrhea, abdominal pain/cramping, bloating, or nausea.
  • Self-reported low fruit and vegetable intake (less than 2 pieces per day).
  • Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
  • If taking oral over-the-counter supplements or herbal remedies targeted at gut comfort, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration.
  • Resides in the United States.
  • Anyone who is willing to follow the study protocol.
  • Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.

Exclusion criteria

Exclusion Criteria:

  • Anyone with chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • Use of antibiotics in the last 15 days.
  • Anyone planning on introducing any products or any new forms of prescription medication or supplements that target gut comfort for the study duration.
  • Anyone with a known history of severe digestive disorders like acid reflux, celiac disease, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), ulcerative colitis, Crohn's disease, or gastrointestinal tract surgeries.
  • 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 taking anticoagulants ('blood thinners') or who has been diagnosed with a bleeding disorder.
  • Anyone who takes medications that may interact with botanical supplements, including but not limited to antihypertensives, blood glucose-lowering agents, anticoagulants/antiplatelet therapies, or medications known to interact with grapefruit.
  • Anyone who has a history of serious illness in the last three months.
  • Anyone who has planned surgery during the study period.
  • Anyone with a history of substance abuse.
  • Anyone who is a heavy drinker (i.e., a woman who drinks eight or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week).
  • 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.
  • Anyone with a chronic hepatic or renal disease.
  • Anyone with a known sulphite sensitivity.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Oxxynea® Supplement

    Dietary Supplement: Oxxynea® Supplement

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementPlacebo

    Participants take one capsule of a matching placebo (maltodextrin 400 mg in a transparent green HPMC capsule, size 0) once daily in the morning with the first meal of the day for six weeks. The placebo is matched to the active product in taste and appearance.

  • Dietary supplementOxxynea® Supplement

    Participants take one capsule of Oxxynea® once daily in the morning with the first meal of the day for six weeks.

06

What researchers measure

Primary outcomes

  1. Change in Gastrointestinal Comfort and Gut Health

    Mean change in the GI symptom subscale of the Gastrointestinal Quality of Life Index (GIQLI) score from Baseline

    Time frame: Baseline, Week 2, Week 4, and Week 6

Secondary outcomes

  1. Change in Physical Functioning

    Mean change in the GIQLI items corresponding to Physical Functioning (part of the 16-item Physical Functioning, Emotional Well-being, and Social Functioning subscale) from Baseline

    Time frame: Baseline, Week 2, Week 4, and Week 6

  2. Change in Emotional Well-being

    Mean change in the GIQLI items corresponding to Emotional Well-being (part of the 16-item Physical Functioning, Emotional Well-being, and Social Functioning subscale) from Baseline

    Time frame: Baseline, Week 2, Week 4, and Week 6

  3. Change in Social Functioning

    Mean change in the GIQLI items corresponding to Social Functioning (part of the 16-item Physical Functioning, Emotional Well-being, and Social Functioning subscale) from Baseline

    Time frame: Baseline, Week 2, Week 4, and Week 6

  4. Change in Participant-Perceived Effects of Medical Treatment

    Mean change in the GIQLI item corresponding to Effects of Medical Treatment from Baseline

    Time frame: Baseline, Week 2, Week 4, and Week 6

  5. Change in Nausea

    Mean change in the GIQLI nausea item score, assessed via an adapted version of the GIQLI questionnaire

    Time frame: Daily for Days 1-14

  6. Change in Abdominal Pain

    Mean change in the GIQLI abdominal pain item score, assessed via an adapted version of the GIQLI questionnaire

    Time frame: Daily for Days 1-14

  7. Change in Bloating

    Mean change in the GIQLI bloating item score, assessed via an adapted version of the GIQLI questionnaire

    Time frame: Daily for Days 1-14

  8. Change in Diarrhea

    Mean change in the GIQLI diarrhea item score, assessed via an adapted version of the GIQLI questionnaire

    Time frame: Daily for Days 1-14

  9. Change in Constipation

    Mean change in the GIQLI constipation item score, assessed via an adapted version of the GIQLI questionnaire

    Time frame: Daily for Days 1-14

07

Study locations

1 site
  • Citruslabs
    Las Vegas, Nevada 89118, United States
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2026 to primary completion in Jun 2026, 0 months.

Of 126 interventional studies with no phase under Nausea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 27, 2026
StartActual
Jun 1, 2026
Primary completionActual
Jun 1, 2026
CompletionActual
Oct 1, 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07898189
Lead sponsor
AB Mauri (UK) Limited,
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Jun 1, 2026
Primary completion
Jun 1, 2026
Completion
Oct 1, 2026
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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