NCT07830992 - A Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults | Crick

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Secondary Outcomes

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

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

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.

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

The difference in postprandial waist circumference area under the curve (AUC₀-₁₂₀ minutes) between Digest Gold and placebo at Day 1.

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

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

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

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.

Time frame: 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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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

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

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

Time frame: Day 1 to Day 6

A Study to Evaluate Acute and Short-term Efficacy of Digest Gold on Postprandial Abdominal Distension and Subjective Bloating in Healthy Adults

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts