A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Gas and Bloating in Healthy Women

Arrae

Status: Begins enrollment in 2 months

Conditions: Bloating; Gastrointestinal Symptoms; Intestinal Gas

Treatments: Other: Placebo; Dietary Supplement: Bloat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07370740

25ARCCB01

Details and patient eligibility

About

The goal of this clinical trial is to investigate the safety and efficacy of Bloat on gas and bloating in healthy women. The main question it aims to answer is what is the change in postprandial gas and bloating from pre-dose at t = 60 mins post-dose between Bloat and placebo, as assessed by Gas and Bloating Likert scale at screening/baseline.

Participants will be asked to consume one dose of Bloat or Placebo and answer questionnaires on gas and bloating.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females aged 18-65 years, inclusive

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 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

3. Recurrent bloating and/or distension occurring on average at least one day per week which predominates over other GI symptoms as assessed by the QI

4. Experiences significant gas and bloating after consumption of the standardized meal provided at screening/baseline, as assessed by a score of 0 (absent) or 1 (mild) pre-meal and a score of 2 (moderate) or 3 (severe) post-meal

5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study

6. Provided voluntary, written, informed consent to participate in the study

7. Healthy as determined by medical history as assessed by Qualified Investigator

Exclusion criteria

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Participants residing in the same household as another study participant unless they are enrolled consecutively (e.g. not actively enrolled at the same time)
3. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of IP, placebo, or standardized meal ingredients
4. 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) as assessed by the QI
5. Unstable metabolic disease or chronic diseases as assessed by the QI
6. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
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 QI on a case-by-case basis
9. 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
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 QI
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 QI
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 QI
14. 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
15. 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
16. Alcohol intake average of >2 standard drinks per day as assessed by the QI
17. Alcohol or drug abuse within the last 12 months
18. 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)
19. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
20. Individuals who are unable to give informed consent
21. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Bloat

Experimental group

Description:

Bloat is comprised of a novel combination of ginger root extract, bromelain, peppermint leaf extract, dandelion root extract, lemon balm herb top extract, and slippery elm inner bark extract.

Treatment:

Dietary Supplement: Bloat

Placebo

Placebo Comparator group

Description:

Placebo is comprised of white rice flour

Treatment:

Other: Placebo