Digestive Alteration [PE]Phase 1NCT01282983
Study of Digestive Tolerance of Orange Juice With Fibers
A Phase 1 study testing Fiber in people with Digestive Alteration [PE], run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Digestive Alteration [PE]
- What is being tested?
- Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Understand and agree with the rules of the study
- Making use of some contraceptive method
- Non-smokers (less than five cigarettes/day)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Lilian M Horie, MsC RD contact
Dan L Waitzberg, MD PhD contact
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, São Paulo
Dan L Waitzberg, MD PhD, dan@ganep.com.br
Lilian M Horie, RD MsC, mikahorie@gmail.com
About this study
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).
Read the 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]
- Being tested
- Fiber, Placebo
- Keywords
- fiber, orange juice, digestive symptom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| fiber | Active comparator | Not described Receives: Dietary Supplement: Fiber |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Frequency of stool - Chart
Secondary outcomes (1)
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
Measured: Unwanted symptoms classification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive Alteration [PE]Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Dan L Waitzberg, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282983
- Sponsor's protocol ID
- IKEA2010
- Status last verified
- Oct 2010
- First submitted
- 20 Jan 2011
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Digestive Tolerance of Orange Juice With Fibers
- ClinicalTrials.gov ID
- NCT01282983
- Acronym / sponsor ID
- IKEA2010
- Conditions
- Digestive Alteration [PE]
- Keywords
- fiber, orange juice, digestive symptom
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiber | Active comparator | Dietary Supplement: Fiber |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiberThe 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. | Dietary supplement | fiber |
| PlaceboThe 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. | Dietary supplement | Placebo |
Primary outcome
Frequency of stool - Chart
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.
1 secondary outcome
Unwanted symptoms classification
Time frame: Unwanted symptoms classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilian M Horie, MsC RD contact
Dan L Waitzberg, MD PhD contact
Dan L Waitzberg, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fiber in people with Digestive Alteration [PE], run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lilian M Horie, MsC RD (mikahorie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of stool - Chart (time frame: Frequency of stool - Chart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.