Study of Digestive Tolerance of Orange Juice With Fibers

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).

Study Overview

• Status: Unknown
• Conditions: Digestive Alteration [PE]
• Intervention / Treatment: Dietary supplement: Fiber; Dietary supplement: Placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Recruiting
      • University of Sao Paulo
      • Contact: Dan L Waitzberg, MD PhD; Email: dan@ganep.com.br
      • Contact: Lilian M Horie, RD MsC; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of stool - Chart	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.	Frequency of stool - Chart

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unwanted symptoms classification	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	Unwanted symptoms classification

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Dan L Waitzberg, MD PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 25, 2011
• Last Update Submitted That Met QC Criteria: January 24, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: orange juice; fiber; digestive symptom
• Other Study ID Numbers: IKEA2010