An Efficacy Trial in the Research Area of Gastrointestinal Health & Bloating

NCT05418127 | Unknown DMC

• 1 other identifier: AFCRO-151
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blinded, placebo-controlled, parallel study, to evaluate the effect of 8-week supplementation of a traditionally fermented organic coconut milk kefir compared to placebo on gastrointestinal symptoms in healthy adults.

Conditions

Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary.

  To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of bloating from baseline to Week 8 (confirmed by selecting a lower category of severity of bloating during the 7-day period prior to end of intervention compared to the 7-day period prior to Baseline on the day with their worst symptom rating).

  8 weeks

Secondary Outcomes (4)

• Change in mean daily severity of Abdominal Pain symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).

  8 weeks

• Change in mean daily severity of Abdominal Discomfort symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).

  8 weeks

• Change in proportion of Participants experiencing Flatulence/Gas symptoms (selecting any option other than 'None' in response to the daily e-diary Flatulence/Gas question).

  8 weeks

• Difference between product groups of self-reported symptom improvement from the Global Impression of Change Scale at end of intervention.

  8 weeks

Other Outcomes (10)

• Change in Hs-CRP

  8 weeks

• Change in microbiome profile

  8 weeks

• Overall product satisfaction questionnaire as measured by the Overall Product Satisfaction Questionnaire

  8 weeks

Study Arms (2)

30 Participants receiving Placebo product.

PLACEBO COMPARATOR

Solution of filtered water, Calcium Carbonate powder, and coconut extract.

Other: Placebo

30 Participants receiving Active product.

ACTIVE COMPARATOR

Traditionally-fermented coconut milk kefir.

Dietary Supplement: Active

Interventions

Active DIETARY_SUPPLEMENT

Traditionally-fermented coconut milk kefir

30 Participants receiving Active product.

Placebo OTHER

Solution of Calcium Carbonate and coconut extract

30 Participants receiving Placebo product.

Eligibility Criteria

• Age: 25 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in the study and comply with its procedures, including but not limited to consuming study product, adhering to visit schedule and e-diary/questionnaires, abstaining from products outlined in Section 5.8 of Study Protocol.
• Able and willing to give written informed consent.
• Adults aged between 25 to 54 years, inclusive.
• Self-reported bloating on at least 3 occasions over the 7-day period immediately prior to enrolment (confirmed by selecting any option other than 'None' in response to the daily electronic diary Bloating question in the electronic diary questionnaire completed prior to enrolment).

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the trial.
• Participants who are lactating and/or currently breastfeeding.
• Participants currently of childbearing potential, but not using an effective method of contraception for at least 30 days prior to dosing, as outlined below:
• Complete abstinence from intercourse prior to administration of the study product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study product in cases where participant discontinues the trial prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
• Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
• Sexual partner(s) is/are exclusively female.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), or contraceptive pill/patch/injection/ring. The participant must be using this method for at least 30 days prior to and 2 weeks following the end of the trial.
• Use of any intrauterine device (IUD) or contraceptive implant. The participant must have the device inserted at least 30 days prior to the first Screening Visit, throughout the trial, and 2 weeks following the end of the trial.
• Participants who have a history of histamine intolerance (i.e., intolerance to fermented food) or any known coconut or tree nut allergy.
• Participants who have consumed prebiotic or probiotic supplements in the 14 days prior to screening (Visit 1).
• Participants have consumed fermented coconut/kefir products in the 14 days prior to screening (Visit 1) and are intending to consume such products during the course of the trial.
• Participants who have used oral antibiotics in the 90 days prior to screening (Visit 1).
• Participants who have any significant health conditions or current medications that would prevent them from fulfilling the trial requirements, put the Participant at risk or would confound the interpretation of the trial results as judged by the investigator on the basis of medical history, medication history, and routine laboratory test results.
• Participants who cannot safety stop taking prescription medication for the duration of the trial
• Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial, these must have been completed not less than 60 days prior to screening (Visit 1).

Sponsors & Collaborators

• Coconut Goodness Food Products Inc.: lead

Study Sites (1)

Atlantia Clinical Trials Ltd.

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stacey Boetto, FNP-C

  Atlantia Clinical Trials Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only one representative of sponsor and two Atlantia Clinical Trials representatives are unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blinded, placebo-controlled, parallel study.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 14, 2022
• Study Start: May 16, 2022
• Primary Completion: November 7, 2022
• Study Completion: March 31, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)