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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462199
• Other study ID #: 18ACHA
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: February 3, 2020

Study information

• Verified date: July 2019
• Source: AIDP, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 3, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation
• Healthy

Intervention

Dietary Supplement:
• Actazin (green kiwi powder) High Dose
Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days
• Actazin (green kiwi powder) Low Dose
Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days
• 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
• Livaux (gold kiwi powder) High Dose
Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days
• Livaux (gold kiwi powder) Low Dose
Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days
• Placebo (microcrystalline cellulose)
Participants will consume 4 capsules containing no active ingredients daily for 28-days

Locations

Country	Name	City	State
Canada	KGK Clinical Trial Centers	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
AIDP, Inc.	KGK Science Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Systolic and diastolic blood pressure.	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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
Secondary	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
Secondary	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.	28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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