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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days
Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days
Participants will consume 4 capsules (150 mg green kiwi powder + 250 mg PreticX prebiotic) daily for 28-days
Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days
Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days
Participants will consume 4 capsules containing no active ingredients daily for 28-days
KGK Clinical Trial Centers
London, Ontario, Canada
The change in complete spontaneous bowel movements between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and Placebo
Assessed by the daily bowel habits diary. A complete spontaneous bowel movements is defined as bowel movements that are both complete and spontaneous.
Time frame: 28 days
The change in spontaneous bowel movements per week between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed using the daily bowel habits diary
Time frame: 28 days
The change in stool form between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the Brstiol Stool Scale (BSS). BSS scores are a measure of stool form. It is on a scale of 1-7, 1 = highly constipated; 7 = diarrhea. A score of type 3-4 are considered normal and movement towards these scores are indicative of healthier bowel functions.
Time frame: 28 days
The change in interval between bowel movements in hours between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed using the daily bowel habits diary
Time frame: 28 days
The change in blood calcium levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by fasting blood sample analysis
Time frame: 28 days
The change in fasting glucose levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by fasting blood sample analysis
Time frame: 28 days
The change in the Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the participants answers to the PAC-SYM questions which assess the severity of patient-reported symptoms of constipation. It is ona scale of 0-4 ( 0= symptoms absent and 4 = severe symptoms.
Time frame: 28 days
The change in the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the participants answers to the PAC-QoL questions. Effect on quality of life is measured on a scale of 0 - 4 (0= no effect on quality of life, and 4 = negative effect on quality of life
Time frame: 28 days
The change in gut microbiome between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by fecal sample analysis
Time frame: 28 days
The percentage of early and late responders to Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the bowel habits diary
Time frame: 28 days
The difference in the Bowel Regularity Index Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the Bowel Regularity Index questionnaire in which participants were provided with a series of twelve statements and asked to score each. Scoring for this index is based on a five-point scale for each question, from strongly disagree (0) to strongly agree (5).
Time frame: 28 days
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