Postprandial Abdominal DistensionNCT07830992
A Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults
A study testing Digest Gold in people with Postprandial Abdominal Distension and Bloating, run by Enzymedica.
Trial summary
The goal of this clinical trial is to investigate the acute and short-term efficacy of Digest Gold on postprandial abdominal distension and subjective bloating in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postprandial Abdominal Distension, Bloating
- What is being tested?
- Digest Gold
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 18 years and older
- 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
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- 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
- 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
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- Agrees to avoid moderate-vigorous exercise (cardio or strength training) or strenuous physical activity 12 hours prior to clinic visits
- Agrees to avoid nonsteroidal anti-inflammatory drugs (NSAIDs) 24 hours prior to clinic visits (Section 7.3.2)
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history and laboratory results as assessed by the Medical Doctor (MD)
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product (IP), placebo, or standardized meal ingredients (e.g., gluten intolerance)
- 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
- Colonoscopy within 14 days of baseline or scheduled colonoscopy during the study period
- Unstable metabolic disease or chronic diseases as assessed by the MD
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the MD (See Section 7.3)
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- Type I or Type II diabetes
- 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
- 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
- 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
- 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
- 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
- Individuals with an autoimmune disease or are immune compromised as assessed by the MD
- Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the MD
- Self-reported confirmation of blood/bleeding disorders as assessed by the MD
- Use of prescribed medical cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- 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
- Alcohol intake average of >2 standard drinks per day as assessed by the MD
- Alcohol or drug abuse within the last 12 months
- 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)
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the MD
- Individuals who are unable to give informed consent
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Triple-blind, Placebo-controlled, Cross-over Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults
The goal of this clinical trial is to investigate the acute and short-term efficacy of Digest Gold on postprandial abdominal distension and subjective bloating in healthy adults. The main question it aims to answer is what is the difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 -120 minutes postprandial), as assessed by the bloating Likert scale?Researchers will compare Digest Gold to a placebo to see its effects on postprandial abdominal distension and bloating. Participants will:
- Consume Digest Gold and a placebo.
- Have height, weight, and waist circumference measured.
- Have blood pressure and heart rate measured.
- Provide blood samples.
- Provide a fecal sample.
- Complete study questionnaires assessing gastrointestinal symptoms and subjective bloating.
- Record their daily food intake.
- Complete a breath test to assess gastrointestinal parameters.
- Conditions
- Postprandial Abdominal Distension, Bloating
- Being tested
- Digest Gold, Placebo
- Keywords
- postprandial abdominal distension, bloating, Digest Gold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digest GoldDietary supplement
At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2.
PlaceboDietary supplement
At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Digest Gold | Experimental | At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2. Receives: Dietary Supplement: Digest Gold |
| Placebo | Placebo comparator | At Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial)
The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial), as assessed by the bloating Likert scale. A four-point Likert scale (absent - 0, mild - 1, moderate - 2, or severe - 3) will be used to measure gas and bloating. A higher score means more severe bloating.
Measured: Day 1
Secondary outcomes (18)
The difference in change between Digest Gold and placebo in abdominal distension
The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1 in abdominal distension, as assessed by waist circumference
Measured: Pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1
The difference in change between Digest Gold and placebo in subjective bloating
The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1 in subjective bloating, as assessed by the gas and bloating Likert scales. A four-point Likert scale (absent - 0, mild - 1, moderate - 2, or severe - 3) will be used to measure gas and bloating. A higher score means more severe bloating.
Measured: Pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1
The difference in postprandial waist circumference area under the curve (AUC₀-₁₂₀ minutes) between Digest Gold and placebo
The difference in postprandial waist circumference area under the curve (AUC₀-₁₂₀ minutes) between Digest Gold and placebo at Day 1.
Measured: Day 1
The difference in maximum postprandial change in waist circumference from the pre-meal measurement between Digest Gold and placebo at Day 1.
The difference in maximum postprandial change in waist circumference from the pre-meal measurement between Digest Gold and placebo at Day 1.
Measured: Day 1
The difference in change in breath methane and hydrogen between Digest Gold and placebo
The difference in change in breath methane and hydrogen between Digest Gold and placebo from pre-dose to time = 60 and 120 minutes postprandial at Day 1, as assessed by the FoodMarble Breath Tester
Measured: Pre-dose to time = 60 and 120 minutes postprandial at Day 1
The difference in postprandial breath methane and hydrogen area under the curve (AUC₀-₁₂₀ minutes) at Day 1 between Digest Gold and placebo
The difference in postprandial breath methane and hydrogen area under the curve (AUC₀-₁₂₀ minutes) at Day 1 between Digest Gold and placebo, as assessed by the FoodMarble Breath Tester.
Measured: Day 1
The difference between Digest Gold and placebo in time-to-relief of subjective gas
The difference between Digest Gold and placebo in time-to-relief of subjective gas, as assessed by the gas Likert scale at Day 1. A four-point Likert scale (absent - 0, mild - 1, moderate - 2, or severe - 3) will be used to measure gas and bloating. A higher score means more severe gas.
Measured: Day 1
Difference in Change in Glucose Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in glucose.
Measured: Day 1
Difference in Change in Insulin Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in insulin.
Measured: Day 1
Difference in Change in Triglyceride Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in triglycerides.
Measured: Day 1
Difference in Change in Total Amino Acid Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
The difference in change between Digest Gold and placebo from pre-dose to time = 15, 30, 60 and 120 minutes postprandial at Day 1 in total amino acids.
Measured: Day 1
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in abdominal distension
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in abdominal distension, as assessed by waist circumference.
Measured: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in breath methane and hydrogen
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in breath methane and hydrogen, as assessed by the FoodMarble Breath Tester.
Measured: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in Gastrointestinal symptoms
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in Gastrointestinal symptoms, as assessed by the modified Gastrointestinal Symptom Rating Scale (GSRS). The modified GSRS includes 14 questions with a four-point Likert scale from 0-3, with lower scores representing better gastrointestinal symptoms.
Measured: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in gas and bloating
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in Gas and bloating, as assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Symptoms (PROMIS-GI) Gas and Bloating Scale 13a. All items are administered using a 5-point categorical response scale. A higher score denotes more gastrointestinal symptoms.
Measured: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in quality of life
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in Quality of life, as assessed by the RAND 36-Item Short Form Health Survey (SF-36). The scores range from 0 to 100 where higher scores indicate a better state of health.
Measured: Day 1 to Day 7
The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for abdominal distension
The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for abdominal distension as assessed by waist circumference
Measured: Day 1 to Day 6
The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for breath methane and hydrogen
The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for breath methane and hydrogen, as assessed by FoodMarble Breath Test
Measured: Day 1 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Abdominal DistensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enzymedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830992
- Sponsor's protocol ID
- 26EMKCR01
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo-controlled, Cross-over Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults
- ClinicalTrials.gov ID
- NCT07830992
- Acronym / sponsor ID
- 26EMKCR01
- Conditions
- Postprandial Abdominal Distension, Bloating
- Keywords
- postprandial abdominal distension, bloating, Digest Gold
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- EnzymedicaIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the acute and short-term efficacy of Digest Gold on postprandial abdominal distension and subjective bloating in healthy adults. The main question it aims to answer is what is the difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 -120 minutes postprandial), as assessed by the bloating Likert scale?Researchers will compare Digest Gold to a placebo to see its effects on postprandial abdominal distension and bloating. Participants will:
- Consume Digest Gold and a placebo.
- Have height, weight, and waist circumference measured.
- Have blood pressure and heart rate measured.
- Provide blood samples.
- Provide a fecal sample.
- Complete study questionnaires assessing gastrointestinal symptoms and subjective bloating.
- Record their daily food intake.
- Complete a breath test to assess gastrointestinal parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digest Gold | Experimental | Dietary Supplement: Digest GoldAt Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAt Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females aged 18 years and older
- 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:
- 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
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
Key exclusion criteria (25 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product (IP), placebo, or standardized meal ingredients (e.g., gluten intolerance)
- 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
- Colonoscopy within 14 days of baseline or scheduled colonoscopy during the study period
- Unstable metabolic disease or chronic diseases as assessed by the MD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digest GoldAt Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2. | Dietary supplement | Digest Gold |
| PlaceboAt Visit 1 (Day 1 of Period 1) and Visit 3 (Day 1 of Period 2), study staff will provide participants with one capsule of study product with water to be consumed with the first bite of the standardized meal. Starting on Day 2 of Period 1, participants will be instructed to take one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner) until Day 6 of Period 1. After a minimum 10-day wash out, participants will return to the study site and will be provided with one capsule of study product to be taken with water at the first bite of the standardized meal. Participants will be instructed to resume daily consumption of the alternate study product (one capsule three times a day with food (at the beginning of breakfast, lunch, and dinner)) from Day 2 until Day 6 of Period 2. | Dietary supplement | Placebo |
Primary outcome
The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial)
Time frame: Day 1
The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial), as assessed by the bloating Likert scale. A four-point Likert scale (absent - 0, mild - 1, moderate - 2, or severe - 3) will be used to measure gas and bloating. A higher score means more severe bloating.
18 secondary outcomes
The difference in change between Digest Gold and placebo in abdominal distension
Time frame: Pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1
The difference in change between Digest Gold and placebo in subjective bloating
Time frame: Pre-dose to time = 15, 30, 60, and 120 minutes postprandial at Day 1
The difference in postprandial waist circumference area under the curve (AUC₀-₁₂₀ minutes) between Digest Gold and placebo
Time frame: Day 1
The difference in maximum postprandial change in waist circumference from the pre-meal measurement between Digest Gold and placebo at Day 1.
Time frame: Day 1
The difference in change in breath methane and hydrogen between Digest Gold and placebo
Time frame: Pre-dose to time = 60 and 120 minutes postprandial at Day 1
The difference in postprandial breath methane and hydrogen area under the curve (AUC₀-₁₂₀ minutes) at Day 1 between Digest Gold and placebo
Time frame: Day 1
The difference between Digest Gold and placebo in time-to-relief of subjective gas
Time frame: Day 1
Difference in Change in Glucose Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
Time frame: Day 1
Difference in Change in Insulin Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
Time frame: Day 1
Difference in Change in Triglyceride Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
Time frame: Day 1
Difference in Change in Total Amino Acid Concentration from Pre-Dose to 15, 30, 60, and 120 Minutes Postprandial Between Digest Gold and Placebo on Day 1
Time frame: Day 1
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in abdominal distension
Time frame: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in breath methane and hydrogen
Time frame: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in Gastrointestinal symptoms
Time frame: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in gas and bloating
Time frame: Day 1 to Day 7
The difference between Digest Gold and placebo in the change from Day 1 (pre-supplementation) to Day 7 following 6 days of supplementation in quality of life
Time frame: Day 1 to Day 7
The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for abdominal distension
Time frame: Day 1 to Day 6
The difference between Digest Gold and placebo in the daily postprandial area under the curve (AUC) during the supplementation period (Day 1 to 6) for breath methane and hydrogen
Time frame: Day 1 to Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Digest Gold in people with Postprandial Abdominal Distension and Bloating, run by Enzymedica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis (+248 1-226-242-4551, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between Digest Gold and placebo in time-to-relief of subjective bloating (time = 0 - 120 minutes postprandial) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.