Study of Digestive Tolerance of Orange Juice With Fibers

NCT ID: NCT01282983

Last Updated: 2011-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-09-30

Brief Summary

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).

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).

Conditions

Digestive Alteration [PE]

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fiber

Group Type: ACTIVE_COMPARATOR

Fiber

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

University of São Paulo

Principal Investigators

Dan L Waitzberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Lilian M Horie, MsC RD

Role: CONTACT

mikahorie@gmail.com

Dan L Waitzberg, MD PhD

Role: CONTACT

dan@ganep.com.br

Facility Contacts

Dan L Waitzberg, MD PhD

Role: primary

dan@ganep.com.br

Lilian M Horie, RD MsC

Role: backup

mikahorie@gmail.com

Other Identifiers

IKEA2010

Identifier Type: -

Identifier Source: org_study_id