A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women

Official title

A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women

Overview

The goal of this clinical trial is to investigate the safety and efficacy of Bloat on postprandial bloating in healthy women. The main question it aims to answer is what is the difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. Participants will be asked to consume one dose of Bloat or Placebo for 55 days, and answer questionnaires on gas, bloating, and abdominal discomfort/distension.

Interventions

• Dietary supplement Bloat
  Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.
• Other Placebo
  Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.

Primary outcome measures

• The difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo [Time frame: Day 1 to Day 56]

Secondary outcome measures (8)

• The difference in change in bloating from pre-dose (postprandial) at t = 30 mins post-dose (postprandial) and t = 120 mins post-dose (postprandial) between Bloat and placebo [Time frame: Day 1 to Day 56]
• The difference in change in gas from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo [Time frame: Day 1 to Day 56]
• The difference in change in abdominal discomfort from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo [Time frame: Day 1 to Day 56]
• The difference in change in GI symptoms from baseline at Day 28 and Day 56 between Bloat and placebo [Time frame: Day 1 to 56]
• The difference in change in GI symptoms from baseline at Day 28 and Day 56 between Bloat and placebo [Time frame: Day 1 to 56]
• The difference in change in GI symptoms from baseline at Day 28 and Day 56 between Bloat and placebo [Time frame: Day 1 to 56]
• The difference in change in gas, bloating, and abdominal distention scores [Time frame: Day 1 to Day 56]
• The difference in change in waist circumference from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo [Time frame: Day 1 to Day 56]

Eligibility criteria

Inclusion criteria

• Females aged 18-65 years, inclusive
• BMI of 18.5 to 29.9 kg/m2, inclusive
• 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 one 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 3 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
• Recurrent bloating and/or distension occurring on average at least one day per week which predominates over other GI symptoms in the previous three months, as assessed by the QI
• Experiences significant bloating after consumption of the standardized meal provided at screening/baseline, as assessed by a score of ≤ 2 pre-meal and a score of ≥ 5 post-meal
• 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 as assessed by QI

Exclusion criteria

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Participants residing in the same household as another study participant unless they are enrolled consecutively (e.g. not actively enrolled at the same time)
• Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of IP, placebo, or standardized meal ingredients
• Current or history of any significant diseases of the GI tract or digestive disorders (e.g., irritable bowel syndrome, celiac disease, inflammatory bowel disease, functional constipation, gastroesophageal reflux disease, being treated within the past year for H. pylori infection or gastric ulcer), use of medications that inhibit peristaltic movement (e.g., opioids, loperamide), esophageal obstruction, or difficulty swallowing, as assessed by the QI
• Individuals with anemia, gallstones, or gallbladder disease as assessed by the QI
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• 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 QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI 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 QI
• 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 QI
• 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 QI
• Chronic use of cannabinoid products (>2 times/week) as assessed by the QI. 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 6 months, as assessed by the QI. 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 QI
• 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 IP (Section 7.3)
• Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
• Individuals who are unable to give informed consent
• Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• KGK Science Inc. — London

Identifiers

NCT: NCT07370740 · 25ARCCB01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗