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.
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,
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
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
Crossover
Digest Gold
Dietary supplementAt 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
Dietary supplementAt 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.
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.
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
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.
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.
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.
Change in gut microbiota composition between Digest Gold and placebo from pre-supplementation to after 7 days of supplementation
Change in gut microbiota composition between Digest Gold and placebo from pre-supplementation to after 7 days of supplementation, as assessed by fecal microbiome analysis
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Clinically relevant changes in blood pressure
Clinically relevant changes in blood pressure (mmHG)
Clinically relevant changes in heart rate
Clinically relevant changes in heart rate (beats per minute)
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Enzymedica
Lead sponsor
KGK Science Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
