Study of Digestive Tolerance of Orange Juice With Fibers

NCT01282983 | Unknown Phase 1 DMC

• 1 other identifier: IKEA2010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Digestive Alteration [PE]

Keywords

fiber; orange juice; digestive symptom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Unwanted symptoms classification

  Unwanted symptoms classification

Study Arms (2)

fiber

ACTIVE COMPARATOR

Dietary Supplement: Fiber

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Fiber 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.

fiber

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dan L Waitzberg, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilian M Horie, MsC RD

CONTACT

mikahorie@gmail.com

Dan L Waitzberg, MD PhD

CONTACT

dan@ganep.com.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 25, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 25, 2011

Record last verified: 2010-10

Locations

BR (1)