Study of Digestive Tolerance of Orange Juice With Fibers

University of Sao Paulo

Status and phase

Unknown

Phase 1

Conditions

Digestive Alteration [PE]

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Fiber

Study type

Interventional

Funder types

Other

Identifiers

NCT01282983

IKEA2010

Details and patient eligibility

About

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).

Full 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).

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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