KGK Clinical Trial Centers
London, Ontario, N6A 5R8, Canada
NCT Number: NCT03462199
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
London, Ontario, N6A 5R8, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All birth control must have been in use for a minimum of three months and the participant must have one regular menstrual cycle in the last 30 days. Acceptable methods of birth control include:
Exclusion criteria
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
Time frame: 28 days
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
Assessed using the daily bowel habits diary
Time frame: 28 days
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
Assessed using the daily bowel habits diary
Time frame: 28 days
Assessed by fasting blood sample analysis
Time frame: 28 days
Assessed by fasting blood sample analysis
Time frame: 28 days
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
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
Assessed by fecal sample analysis
Time frame: 28 days
Assessed by the bowel habits diary
Time frame: 28 days
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: up to 45 days for non-supplement emergent AE's, and 28-days for supplement emergent AE's
The incidence of adverse events (AEs) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on systolic and diastolic blood pressure.
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on heart rate.
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on body weight.
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on body mass index (BMI).
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on fasting glucose
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Alanine Transaminase
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Aspartate Transaminase
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Total Bilirubin
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Creatinine
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Sodium ion
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Potassium ion
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Chloride ion
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Estimated Glomerular Filtration Rate (eGFR)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on White Blood Cell Count
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Red Blood Cell
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Hemoglobin
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Hematocrit
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Platelet Count
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Mean corpuscular Volume (MCV)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Mean corpuscular Hemoglobin (MCH)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Mean corpuscular Hemoglobin Concentration (MCHC)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Neutrophil Count (NEUTS)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Lymphocyte Count (LYMP)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Monocyte Count (MONO)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Eosinophil Count (EOS)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Basophil Count (BASO)
Time frame: Measured at baseline and end-of-study (28 days)
The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Red Cell Distribution Width (RDW)
AIDP, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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