NCT03462199

Evaluating Efficacy of Investigational Products on Spontaneous Bowel Movements in Healthy People With ≤ 3 Complete Weekly Spontaneous Bowel Movements

A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of the Investigational Products on Complete Spontaneous Bowel Movements in Participants Who Normally Have ≤ 3 Complete Spontaneous Bowel Movements Per Week But Are Otherwise Healthy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: AIDP, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Low and High doses of Actazin and Livaux will be compared against a control formula and placebo to evaluate how each investigational study product effects complete spontaneous bowel movements in healthy adults that currently experience less than or equal to 3 complete spontaneous bowel movements per week. During the 28-day study period, it is hypothesized that participants consuming Acatzin, Livaux, or control formula will have an increased number of complete spontaneous bowel movements when compared to participants consuming the placebo. It is hypothesized that participants consuming Actazin or Livaux will respond more than participants consuming the control formula. It is hypothesized that participants consuming Actazin or Livaux will have a favorable microbiome change than placebo.

Conditions

• Functional Constipation
• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Actazin (green kiwi powder) High Dose	Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days
DIETARY_SUPPLEMENT	Actazin (green kiwi powder) Low Dose	Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days
DIETARY_SUPPLEMENT	Control Formula (Actazin green kiwi powder + PreticX prebiotic)	Participants will consume 4 capsules (150 mg green kiwi powder + 250 mg PreticX prebiotic) daily for 28-days
DIETARY_SUPPLEMENT	Livaux (gold kiwi powder) High Dose	Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days
DIETARY_SUPPLEMENT	Livaux (gold kiwi powder) Low Dose	Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days
DIETARY_SUPPLEMENT	Placebo (microcrystalline cellulose)	Participants will consume 4 capsules containing no active ingredients daily for 28-days

Timeline

• Start date: 2018-03-23
• Primary completion: 2020-02-01
• Completion: 2020-02-03
• First posted: 2018-03-12
• Last updated: 2020-07-14

Locations

1 site across 1 country: Canada