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

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

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

Sponsors & Collaborators

• KGK Science Inc.

  collaborator INDUSTRY

• AIDP, Inc.

  lead INDUSTRY

Principal Investigators

• David Crowley, MD · KGK Science Inc.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-23

Primary Completion

2020-02-01

Completion

2020-02-03

Countries

• Canada

Study Locations