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Can a digestive enzyme pill beat the bloat? trial puts digest gold to the test
NCT ID NCT07830992
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether Digest Gold, a digestive enzyme supplement, eases bloating and belly distension after meals in healthy adults. The trial compares Digest Gold with a placebo in 30 participants who take capsules with a standardized meal and for several days afterward. Participants report bloating symptoms, have waist measurements, and give blood and stool samples. The main question is how quickly bloating relief occurs within two hours of eating.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a digestive enzyme supplement called Digest Gold
- What this could lead to
- If it works, Digest Gold could offer a simple over-the-counter option for people who feel bloated and distended after eating. It could also support the idea that digestive enzymes help break down meals more comfortably.
- What could go wrong
- This is a small, early study of 30 healthy adults, so any benefit may be modest and may not apply to people with digestive conditions. Supplements can cause mild stomach upset, and the placebo-controlled design means some participants will not receive the active product.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females aged 18 years and older 2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomy of partner at least 6 months prior to screening * Abstinence and agrees to use contraception if planning on becoming sexually active during the study 3. Self-reported post-meal bloating or abdominal distension at least one day per week AND confirmation of a history of bloating or abdominal distension following consumption of meals similar to the study-specific standardized meal 4. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits 5. Agrees to avoid moderate-vigorous exercise (cardio or strength training) or strenuous physical activity 12 hours prior to clinic visits 6. Agrees to avoid nonsteroidal anti-inflammatory drugs (NSAIDs) 24 hours prior to clinic visits (Section 7.3.2) 7. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 8. Provided voluntary, written, informed consent to participate in the study 9. Healthy as determined by medical history and laboratory results as assessed by the Medical Doctor (MD) Exclusion Criteria: 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product (IP), placebo, or standardized meal ingredients (e.g., gluten intolerance) 3. Current or history of any significant diseases of the gastrointestinal tract or digestive disorders (e.g., celiac disease, inflammatory bowel disease, functional constipation, unstable gastroesophageal reflux disease, unstable gallstones), as assessed by the MD 4. Colonoscopy within 14 days of baseline or scheduled colonoscopy during the study period 5. Unstable metabolic disease or chronic diseases as assessed by the MD 6. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the MD (See Section 7.3) 7. Type I or Type II diabetes 8. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the MD on a case by-case basis 9. History of or current diagnosis with kidney and/or liver diseases as assessed by the MD on a case by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months 10. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the MD 11. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the MD 12. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable 13. Individuals with an autoimmune disease or are immune compromised as assessed by the MD 14. Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the MD 15. Self-reported confirmation of blood/bleeding disorders as assessed by the MD 16. Use of prescribed medical cannabinoid products 17. Chronic use of cannabinoid products (\>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period 18. Regular use of tobacco or nicotine products in the past six months, as assessed by the MD. Occasional users will be required to washout and abstain for the duration of the study period 19. Alcohol intake average of \>2 standard drinks per day as assessed by the MD 20. Alcohol or drug abuse within the last 12 months 21. Current use of prescribed and/or Over-the-Counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3) 22. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit 23. Participation in other clinical research studies 30 days prior to baseline, as assessed by the MD 24. Individuals who are unable to give informed consent 25. Any other condition or lifestyle factor, that, in the opinion of the MD, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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