Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants

Official title

A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Investigate the Safety and Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants

Overview

The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. The main question it aims to answer is whether Bloat gummies reduce post-meal bloating, gas, or abdominal pain (stomach) discomfort. Participants will be asked to consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating and abdominal distension.

Interventions

• Dietary supplement Bloat Gummies
  Participants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart.
• Dietary supplement Placebo
  Participants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart.

Primary outcome measures

• Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo. [Time frame: Evaluated from pre-dose to 60 minutes post-dose]

Secondary outcome measures (5)

• Mean change in bloating severity from pre-dose to t = 30 minutes post-dose, comparing active product vs placebo. [Time frame: Evaluated from pre-dose to 30 minutes post-dose]
• Mean change in gas severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo. [Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.]
• Mean change in abdominal discomfort severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo. [Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.]
• Mean change in waist circumference from pre-dose to t = 30 and t = 60 minutes post-dose, comparing active product vs. placebo. [Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.]
• Proportion of participants demonstrating a reduction in waist circumference. [Time frame: Evaluated at 30 minutes, 60 minutes or both timepoints post-dose.]

Eligibility criteria

Inclusion criteria

• Healthy male and female individuals aged 18-65 years at time of screening.
• Body mass index (BMI) <29.9 kg/m².
• Self-reported recurrent postprandial abdominal bloating and/or distension occurring on average at least 2 days per week over the past 3 months, predominating over other gastrointestinal (GI) symptoms, and in the absence of a diagnosed gastrointestinal disease.
• Females of child-bearing potential must have a negative baseline pregnancy test and agree to use a medically approved method of birth control for the duration of the study.
• Willing to consume a standardized test meal consisting of 2 slices of large cheese pizza from Dominos on each test day.
• Willing to complete online surveys and at-home measurements (waist circumference) at scheduled time points.
• Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study.
• Provides voluntary, written, informed consent to participate in the study prior to any study procedures.
• Has reliable access to internet and a smartphone or computer capable of completing electronic surveys and attending virtual check-ins.

Exclusion criteria

• Current or past diagnosis of any significant disease of the GI tract, including but not limited to: irritable bowel syndrome (IBS), celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), functional constipation, gastroesophageal reflux disease (GERD), gastroparesis, or treatment for H. pylori infection or gastric ulcer within the past year.
• Significant or untreated medical and/or psychiatric disorders, including but not limited to: severe unstable diabetes, recent myocardial ischemia or infarction, unstable angina, cancer (except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative or volunteers with cancer in full remission for more than five years after diagnosis are acceptable), uncontrolled hypertension, renal failure, chronic active hepatitis, acute hepatitis, cirrhosis, Acquired Immunodeficiency Syndrome (AIDS), malignancy, and neurological disorders including epilepsy, recent cerebrovascular disease, or recent traumatic brain injury.
• Current use of digestive enzyme supplements, prebiotics/fibers, probiotics, postbiotics, bloating-targeted supplements, therapeutic iron supplementation (>65 mg elemental iron per dose), prokinetic agents, antacids, H2 blockers, proton pump inhibitors (PPIs), opioids, or loperamide within 14 days prior to the first test meal session; or use of any of the above during the study period.
• Esophageal obstruction or difficulty swallowing.
• Wear dentures.
• Pregnant, breastfeeding, or planning to become pregnant during the study.
• Known allergy, or sensitivity to any ingredient of the study supplement or placebo, including ginger, lemon balm, dandelion, or Bifidobacterium longum-derived products.
• Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of standardized meal ingredients.
• Alcohol use disorder or drug abuse/dependence within the past 6 months (>2 standard drinks/day on average).
• Currently following an extremely restrictive diet or having done so within the past 3 months.
• Participation in another clinical research trial within 30 days prior to randomization.
• Cognitively impaired or unable to provide informed consent.
• Any other condition that, in the Investigator's opinion, may adversely affect the participant's ability to complete the study or its measures, or that may 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: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Other

Study locations

United States · 1 center

• Alethios, Inc. — San Francisco

Identifiers

NCT: NCT07516587 · ARR001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗