A Randomized, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of Traditionally Fermented Organic Coconut Milk Kefir on Gastrointestinal Symptoms in Healthy Adults

Coconut Goodness Food Products Inc.1 site in 1 country60 target enrollmentMay 16, 2022

ConditionsGastrointestinal Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Dysfunction
Sponsor: Coconut Goodness Food Products Inc.
Enrollment: 60
Locations: 1
Primary Endpoint: Change in proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary.
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 16, 2022

End Date

March 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Coconut Goodness Food Products Inc.

Responsible Party

Principal Investigator

Linda Peers

Principal Investigator

Coconut Goodness Food Products Inc.

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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).

Outcomes

Primary Outcomes

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

Time Frame: 8 weeks

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).

Secondary Outcomes

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