Study of Digestive Tolerance of Orange Juice With Fibers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01282983
First received: January 20, 2011
Last updated: January 24, 2011
Last verified: October 2010
  Purpose

Dietary fiber (commonly called bulk or roughage) is the edible nondigestible component of carbohydrate and lignin naturally found in plant food; however, bacteria in the lower gut may metabolize part of it. Epidemiological studies have found that fiber intake in the population is below the suggested recommendations. The beneficial effects of the fibers in human health are recognized. The regular intake of dietary fiber has an important role in the intestinal function increasing the intestinal fecal and reducing the transit time along the intestine; collaborates with the LDL-cholesterol plasmatic reduction by increasing fecal excretion of cholesterol and bile acids, decreases postprandial glucose in healthy, diabetics and insulin resistant people, reduces the risk for developing certain cancers, promotes satiety, helps with weight loss, and exerts immunomodulatory effect. However, fiber intake may be associated with adverse effects such as flatulence, bloating, cramps, and daily consumption of orange juice to bring digestive problems associated with acidity and heartburn, epigastric burning. Then it becomes of interest to study the tolerance of a new orange juice product fortified with mixed fibers (fructooligosaccharides, resistant dextrin, polydextrose and lactulose).


Condition Intervention Phase
Digestive Alteration [PE]
Dietary Supplement: Fiber
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Digestive Tolerance of Orange Juice With Fibers

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Frequency of stool - Chart [ Time Frame: Frequency of stool - Chart ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Unwanted symptoms classification [ Time Frame: Unwanted symptoms classification ] [ Designated as safety issue: Yes ]
    The daily graduation of nuisance for abdominal pain, flatulence, abdominal distension, nausea and vomiting using the classification for unwanted symptoms, with 4-point scale, after 3 weeks consumption of product with the information obtained with the standard orange juice consumption from the participant diary


Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fiber Dietary Supplement: Fiber
The study consists of 21 days consumption of Orange juice. The volunteers will be instructed to consume 200ml of juice twice a day (1 pack of 200ml at lunch and one at dinner) with 4grams of fiber in each pack.
Placebo Comparator: Placebo Dietary Supplement: Placebo
The study consists of 21 days consumption of Orange juice. The volunteers will be instructed to consume 200ml of juice twice a day (1 pack of 200ml at lunch and one at dinner) without fiber.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282983

Contacts
Contact: Lilian M Horie, MsC RD mikahorie@gmail.com
Contact: Dan L Waitzberg, MD PhD dan@ganep.com.br

Locations
Brazil
University of São Paulo Recruiting
São Paulo, SP, Brazil
Contact: Dan L Waitzberg, MD PhD       dan@ganep.com.br   
Contact: Lilian M Horie, RD MsC       mikahorie@gmail.com   
Principal Investigator: Dan L Waitzberg, MD PhD         
Sub-Investigator: Ana P Muniz Pereira, RD         
Sub-Investigator: Cecilia Jardini Marques, RD         
Sub-Investigator: Glaucia M Shiroma, RD         
Sub-Investigator: Juliana Lopes Frias, RD         
Sub-Investigator: Lidiane A Catalani, RD         
Sub-Investigator: Lilian M Horie, RD MsC         
Sub-Investigator: Liria Nubia Alvarenga, RD         
Sub-Investigator: Maria Carolina Gonçalves Dias, RD MsC         
Sub-Investigator: Maria Cláudia Ortolani, RD         
Sub-Investigator: Maria de Lourdes Teixeira da Silva, MD MsC         
Sub-Investigator: Maria Manuela Ferreira Alves, RD         
Sub-Investigator: Priscila Carasin Garla, RD         
Sub-Investigator: Ricardo Alexandre Garib, MD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Dan L Waitzberg, MD PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Dan Linetzky Waitzberg - Professor, University of São Paulo
ClinicalTrials.gov Identifier: NCT01282983     History of Changes
Other Study ID Numbers: IKEA2010
Study First Received: January 20, 2011
Last Updated: January 24, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
fiber
orange juice
digestive symptom

ClinicalTrials.gov processed this record on August 28, 2014