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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Actazin High Dose | Experimental |
| |
| Actazin Low Dose | Experimental |
| |
| Control Formula | Active Comparator |
| |
| Livaux High Dose | Experimental |
| |
| Livaux Low Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actazin (green kiwi powder) High Dose | Dietary Supplement | Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| The change in stool form between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | The incidence of adverse events (AEs) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo. | up to 45 days for non-supplement emergent AE's, and 28-days for supplement emergent AE's |
| Systolic and diastolic blood pressure. |
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:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Clinical Trial Centers | London | Ontario | N6A 5R8 | Canada |
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randomized, double-blind, placebo controlled, parallel study
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| Actazin (green kiwi powder) Low Dose | Dietary Supplement | Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days |
|
| Control Formula (Actazin green kiwi powder + PreticX prebiotic) | Dietary Supplement | Participants will consume 4 capsules (150 mg green kiwi powder + 250 mg PreticX prebiotic) daily for 28-days |
|
| Livaux (gold kiwi powder) High Dose | Dietary Supplement | Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days |
|
| Livaux (gold kiwi powder) Low Dose | Dietary Supplement | Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days |
|
| Placebo (microcrystalline cellulose) | Dietary Supplement | Participants will consume 4 capsules containing no active ingredients daily for 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. |
| 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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). | 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. |
| Measured at baseline and end-of-study (28 days) |
| Heart rate. | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on heart rate. | Measured at baseline and end-of-study (28 days) |
| Body weight. | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on body weight. | Measured at baseline and end-of-study (28 days) |
| Body mass index (BMI). | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on body mass index (BMI). | Measured at baseline and end-of-study (28 days) |
| Fasting glucose | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on fasting glucose | Measured at baseline and end-of-study (28 days) |
| Alanine Transaminase | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Alanine Transaminase | Measured at baseline and end-of-study (28 days) |
| Aspartate Transaminase | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Aspartate Transaminase | Measured at baseline and end-of-study (28 days) |
| Total Bilirubin | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Total Bilirubin | Measured at baseline and end-of-study (28 days) |
| Creatinine | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Creatinine | Measured at baseline and end-of-study (28 days) |
| Sodium ion | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Sodium ion | Measured at baseline and end-of-study (28 days) |
| Potassium ion | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Potassium ion | Measured at baseline and end-of-study (28 days) |
| Chloride ion | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Chloride ion | Measured at baseline and end-of-study (28 days) |
| Estimated Glomerular Filtration Rate (eGFR) | 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) | Measured at baseline and end-of-study (28 days) |
| White Blood Cell Count | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on White Blood Cell Count | Measured at baseline and end-of-study (28 days) |
| Red Blood Cell | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Red Blood Cell | Measured at baseline and end-of-study (28 days) |
| Hemoglobin | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Hemoglobin | Measured at baseline and end-of-study (28 days) |
| Hematocrit | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Hematocrit | Measured at baseline and end-of-study (28 days) |
| Platelet Count | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Platelet Count | Measured at baseline and end-of-study (28 days) |
| Mean corpuscular Volume (MCV) | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Mean corpuscular Volume (MCV) | Measured at baseline and end-of-study (28 days) |
| Mean corpuscular Hemoglobin (MCH) | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Mean corpuscular Hemoglobin (MCH) | Measured at baseline and end-of-study (28 days) |
| Mean corpuscular Hemoglobin Concentration (MCHC) | 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) | Measured at baseline and end-of-study (28 days) |
| Absolute Neutrophil Count (NEUTS) | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Neutrophil Count (NEUTS) | Measured at baseline and end-of-study (28 days) |
| Absolute Lymphocyte Count (LYMP) | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Lymphocyte Count (LYMP) | Measured at baseline and end-of-study (28 days) |
| Absolute Monocyte Count (MONO) | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Monocyte Count (MONO) | Measured at baseline and end-of-study (28 days) |
| Absolute Eosinophil Count (EOS) | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Eosinophil Count (EOS) | Measured at baseline and end-of-study (28 days) |
| Absolute Basophil Count (BASO) | The effect of Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo on Absolute Basophil Count (BASO) | Measured at baseline and end-of-study (28 days) |
| Red Cell Distribution Width (RDW) | 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) | Measured at baseline and end-of-study (28 days) |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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