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

NCT03462199 | Completed

• 1 other identifier: 18ACHA
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation; Healthy

Keywords

Kiwi; Constipation; Bowel Movements; Healthy; Functional Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

  28 days

• The change in stool form between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.

  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.

  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.

  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.

  28 days

Other Outcomes (28)

• Adverse events (AEs)

  up to 45 days for non-supplement emergent AE's, and 28-days for supplement emergent AE's

• Systolic and diastolic blood pressure.

  Measured at baseline and end-of-study (28 days)

• Heart rate.

  Measured at baseline and end-of-study (28 days)

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo (microcrystalline cellulose)

Actazin High Dose

EXPERIMENTAL

Dietary Supplement: Actazin (green kiwi powder) High Dose

Actazin Low Dose

EXPERIMENTAL

Dietary Supplement: Actazin (green kiwi powder) Low Dose

Control Formula

ACTIVE COMPARATOR

Dietary Supplement: Control Formula (Actazin green kiwi powder + PreticX prebiotic)

Livaux High Dose

EXPERIMENTAL

Dietary Supplement: Livaux (gold kiwi powder) High Dose

Livaux Low Dose

EXPERIMENTAL

Dietary Supplement: Livaux (gold kiwi powder) Low Dose

Interventions

Actazin (green kiwi powder) High Dose DIETARY_SUPPLEMENT

Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days

Actazin High Dose

Actazin (green kiwi powder) Low Dose DIETARY_SUPPLEMENT

Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days

Actazin Low Dose

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

Control Formula

Livaux (gold kiwi powder) High Dose DIETARY_SUPPLEMENT

Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days

Livaux High Dose

Livaux (gold kiwi powder) Low Dose DIETARY_SUPPLEMENT

Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days

Livaux Low Dose

Placebo (microcrystalline cellulose) DIETARY_SUPPLEMENT

Participants will consume 4 capsules containing no active ingredients daily for 28-days

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AIDP, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Clinical Trial Centers

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Constipation

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo controlled, parallel study

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: March 23, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 3, 2020
• Last Updated: July 14, 2020

Record last verified: 2019-07

Locations

CA (1)