Clinical trial NCT03462199: Evaluating Efficacy of Investigational Products on Spontaneous Bowel Movements in Healthy People With ≤ 3 Complete Weekly Spontaneous Bowel Movements
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Healthy
Keywords: Kiwi
Constipation
Bowel Movements
Healthy
Functional Constipation
Lead sponsor: AIDP, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2018-03-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo controlled, parallel study
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Males and females 18 to 60 years of age, inclusive at baseline
* Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) or,

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:

* Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
* Double-barrier method
* Intrauterine devices
* Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
* Vasectomy of partner (shown successful as per appropriate follow-up)
* Body mass index (BMI) between 19 and 29.9 ±1 kg/m2 at screening, inclusive
* Participants must have the following criteria based on participant self-reporting:
* Self-reported ≤ 3 CSBMs per week at screening and confirmed in the BHD during the run-in period for enrolment at baseline
* People who are not regular consumers of, high fibre diets, yoghurt, fermented foods such as kimchi, kombucha, sauerkraut etc.
* Fasting blood glucose ≤6.0 mmol/L at screening
* Agree to refrain from the consumption high-fiber dietary supplements including Metamucil, Benefibre, and Phloe
* Agree to refrain from the consumption of fresh kiwifruit 2-weeks prior to and during the study
* Agree to maintain their habitual food and beverage intakes
* Agree to maintain current physical activity patterns
* Agree to avoid overseas travel for the duration of the study due to the impact this may have on diet and gastrointestinal health
* Healthy as determined by laboratory results, medical history, and physical exam as assessed by the Qualified Investigator
* Willingness to complete questionnaires, records, and diaries associated with the study, collect stool samples, and to complete all clinic visits
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Women who are pregnant, breast feeding, or planning to become pregnant during the trial
* Participation in a clinical research trial within 30 days prior to randomization
* Blood donation during the study or within 30 days of completing the study
* Vegan, raw food, or very high-fiber diet, including regular consumption of foods labeled as supplemented with fiber.
* Weight loss of \>5% within the past 3 months
* Frequent use of laxatives defined as greater than once per week.
* Use of medications such as antibiotics that have major impact on gut microbes 2 months prior to baseline and as assessed case by case by the QI
* Use of probiotic and prebiotic dietary supplements.
* Regular intake of nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or other anti-inflammatory medications
* Use of medications for constipation and or Diarrhea as assessed by QI
* Allergy or sensitivity to kiwifruit or other test product ingredients
* Prior surgery for weight loss (lap band or gastric bypass)
* Gastrointestinal alarm symptoms including blood in stools, frequent diarrhea, and unremitting abdominal pain, and major diseases of the gastrointestinal tract (such as IBS, Crohn's, etc.), pulmonary or endocrine systems, or other GI abnormalities
* Gastroparesis or lactose intolerance
* Current, or history of, thyroid disease
* Uncontrolled hypertension (SBP ≥160 mmHg) assessed by QI
* Renal, hepatic, pancreatic, or biliary impairment or disease as disclosed or detected (if applicable) by chemistry and hematology taken at screening
* Current, or history of, bleeding/blood disorders
* Type I and Type II diabetes
* Autoimmune disease or immuno-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive)
* Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis will be considered as per the QI's opinion
* Clinically significant abnormal laboratory results at screening
* Alcohol or drug abuse within the last 6 months
* Participants with a history of cigarette smoking within the past 5 years.
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the qualified investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant

Primary outcomes:
measure: The change in complete spontaneous bowel movements between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and Placebo
timeFrame: 28 days
Secondary outcomes:
measure: 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.
timeFrame: 28 days
measure: The change in stool form between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: The change in blood calcium levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
timeFrame: 28 days
measure: The change in fasting glucose levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: The change in gut microbiome between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
timeFrame: 28 days
measure: The percentage of early and late responders to Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
timeFrame: 28 days
measure: The difference in the Bowel Regularity Index Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
timeFrame: 28 days
Other outcomes:
measure: Adverse events (AEs)
timeFrame: up to 45 days for non-supplement emergent AE's, and 28-days for supplement emergent AE's
measure: Systolic and diastolic blood pressure.
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Heart rate.
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Body weight.
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Body mass index (BMI).
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Fasting glucose
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Alanine Transaminase
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Aspartate Transaminase
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Total Bilirubin
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Creatinine
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Sodium ion
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Potassium ion
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Chloride ion
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: White Blood Cell Count
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Red Blood Cell
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Hemoglobin
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Hematocrit
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Platelet Count
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Mean corpuscular Volume (MCV)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Mean corpuscular Hemoglobin (MCH)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Mean corpuscular Hemoglobin Concentration (MCHC)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Absolute Neutrophil Count (NEUTS)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Absolute Lymphocyte Count (LYMP)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Absolute Monocyte Count (MONO)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Absolute Eosinophil Count (EOS)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Absolute Basophil Count (BASO)
timeFrame: Measured at baseline and end-of-study (28 days)
measure: Red Cell Distribution Width (RDW)
timeFrame: Measured at baseline and end-of-study (28 days)
Locations:
city: London
country: Canada
facility: KGK Clinical Trial Centers
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: