Study of Digestive Tolerance of Orange Juice With Fibers
18 Years
45 Years
Female
Digestive Alteration [PE]
Trial Information
Study of Digestive Tolerance of Orange Juice With Fibers
Monocentric, double blind, randomized, two parallel arms controlled placebo study. 200
healthy women from 18 to 45 years old, without functional digestive disorders or diagnosed
digestive disease will take part in the study. The study consists of 21 days consumption of
Orange juice. The participants will be randomized in two groups: placebo (Orange juice
without fiber - control) and study group (Orange juice fortified with fiber mix). In both
groups, the volunteers will be instructed to consume 200ml of juice twice a day (1 pack of
200ml at lunch and one at dinner).
Inclusion Criteria:
- Healthy
- Tolerate the intake of orange juice routinely (at least twice/month)
- Do not use antibiotics, industrial fibers or supplements containing industrialized
fibers, prebiotics and probiotics for 30 days before the start of the study
- BMI between 18,5 a 29,9 Kg/m2
- Body weight stable during the last two months
- Able to have good communication with the researcher
- Understand and agree with the rules of the study
- Making use of some contraceptive method
- Non-smokers (less than five cigarettes/day)
Exclusion Criteria:
- Illiterate
- Severe alcoholics
- Allergy to orange and its juice
- Any other allergy or food intolerance
- Disease or disorder of the upper digestive tract diagnosed and treated in the last
twelve months
- Inflammatory bowel diseases
- Irritable bowel syndrome
- To have diarrhea (three liquid evacuations a day)
- Pregnancy
- Lactation
- Any history of eating disorder
- Declared diseases:
- Renal insufficiency
- Hepatic Insufficiency
- Chronic Heart Failure
- Other disease which in the opinion of the investigator might be inconsistent
with the study
- Be in dialysis process
- Chronic renal failure
- History or evidence of organic disease of the gastrointestinal tract
- History of cancer within five previous years (except basal cell carcinoma well
treated or cervical carcinoma in situ)
- History or evidence of metabolic disturbs
- History of gastric surgery intervention (except appendectomy)
- Being under some weight loosing process or diet
- Refuse to sign the Informed Consent Term
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Frequency of stool - Chart
Outcome Description:
Bristol scale with classification type 1 to type 7 will be used for self-information on daily frequency of bowel movements and consistency of the feces.
Outcome Time Frame:
Frequency of stool - Chart
Safety Issue:
Yes
Principal Investigator
Dan L Waitzberg, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Sao Paulo
Authority:
Brazil: Ethics Committee
Study ID:
IKEA2010
NCT ID:
NCT01282983
Start Date:
October 2010
Completion Date:
September 2011
Related Keywords:
- Digestive Alteration [PE]
- fiber
- orange juice
- digestive symptom
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