Clinical Drug Experience Knowledgebase

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