Actazin(TM) for improved digestive health

Not Applicable

• Conditions: Digestive Health; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12612001270808
• Lead Sponsor: Stratum Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Aged 18 – 55 years (to avoid age groups where possible undiagnosed cancer may start to be an issue).
BMI limits between 19 and 30 k/m2.
Fasting blood glucose under 5.6mmol /L.
Subjects will be required to be willing to maintain his or her habitual food and beverage intake (other than substitution of study food for similar products) and physical activity pattern throughout the study period. Subjects will be asked to exclude high fibre supplements such as Metamucil (Registered Trademark), Benefibre (Registered Trademark) and Phloe(TM) as well as refraining from eating fresh kiwifruit for the study period.
Participants will also have to avoid overseas travel for the period of the study due to the impact this may have on diet.

Exclusion Criteria

Presence of gastrointestinal alarm symptoms (including blood in stools, frequent diarrhoea, unremitting abdominal pain)
Dieters or people who are following vegan, raw food diets or very high fibre diets
Gastroparesis or lactose intolerance
Surgery for weight loss (lapband or gastric bypass)
Pregnant women
Clinically significant renal, hepatic, endocrine, cardiac, pulmonary, pancreatic, neurological, hematologic or biliary disorders
Known allergy or sensitivity to kiwifruit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant increase in stool frequency assessed by daily diaries[Week 2,6,8,12,14,18,20,24,26]

Secondary Outcome Measures

Name	Time	Method
Clinical secondary endpoints will be significant improvement in stool form (Bristol stool scale)[Week 2,6,8,12,14,18,20,24,26];Improvement in symptoms of Irritable bowel syndrome as assessed by IBS questionnaire[Week 2,6,8,12,14,18,20,24,26];Improvement in quality of life as assesed by QoL questionnaire[Week 2,6,8,12,14,18,20,24,26]