HealthyMEFNCT00775567
Effect of Fructose on Colonic Microflora
A study testing Fructose powder in people with Healthy, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial summary
Fructose is the principal carbohydrate in fruits and is added to many food products. This 6 carbon sugar is associated with a number of ill effects, like promotion of high triglycerides,precipitation of gout in men,possible depression in women and symptoms of intolerance in a non ethnic dose dependent fashion.However… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fructose powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
Who cannot join
- Antibiotics 90 days pre entry
- Use of gastrointestinal motility drugs eg loperamide, metoclopramide significant fiber supplements
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colonic Microbial and Clinical Adaptation to Large Doses of Fructose
Fructose is the principal carbohydrate in fruits and is added to many food products. This 6 carbon sugar is associated with a number of ill effects, like promotion of high triglycerides,precipitation of gout in men,possible depression in women and symptoms of intolerance in a non ethnic dose dependent fashion.However, high fruit and vegetable intake is associated with some epidemiologic evidence in prevention of some cancers like stomach and colorectum.The principal protectors in these products are thought to be antioxidants and other protective chemicals like polyphenols.In addition long chain polymers of fructose:inulin are thought to help protect against cancer through prebiotic effects. In fact poly-fructose molecules are used as prebiotic food supplements and are promoted as aids for a healthy intestine with "balanced microflora".
Polyfructose prebiotics induce some gastrointestinal symptoms of cramps gas bloating and sometimes diarrhea.To date repeated consumption of these polyfructose molecules have not been shown to induce colonic adaptation. Nor is there evidence that fructose intolerant people "adapt " to prolonged ingestion.
These findings are in contrast to findings with lactose intolerance where prolonged ingestion leads to both symptomatic and physiological adaptation.In this interventional study we evaluate whether fructose intolerant people can adapt to moderate dose daily fructose ingestion.The desired outcome is symptomatic, physiological and colonic microfloral adaptation. A failure to detect an increase in bifidobacteria on retesting may suggest that in humans like in some other mammals GLUT5 fructose transport could be induced.
Read the detailed description
The concept of Colonic Adaptation(CA) to regular carbohydrates has been linked mainly to lactose disaccharide(galactose,glucose) and lactulose(galactose, fructose), a manufactured derivative of lactose. CA is achieved in both cases by short term regular consumption of the targeted sugar which is not digested by the host. The clinical definition of CA includes a measured change in breath hydrogen, reduction of clinical symptoms (Bloat, gas, cramps and at times diarrhea) and an associated increase of bacterial lactase(β-galactosidase. The putative mechanism is through bacterial action which results in enhanced metabolism or expanded bacterial population of specific genus and species of bacteria. The act of CA may incur health benefits through physicochemical changes and especially promotion of health promoting bacteria.
Maldigestion of fructose occurs in the population probably in a dose dependent fashion. The sugar content overwhelms the principal GLUT5 intestinal carrier. In the presence of glucose this non energy dependent system works better(11). In a previous publication we found that the pre test graded ingestion of fructose had no impact on test results. These results were dramatically different from that found for pretest lactose ingestion. The investigators interpreted the results from the fructose study as being consistent with a failure to show CA to regular fructose consumption.
More recently Rao et al however, showed that there may be a threshold level of intake beyond which fructose maldigestion may rapidly increase. This value was thought to be 15-20g. In the case of lactose this was 10g(15). Since in both our studies we used the same dose response analysis(<10,11-19, and >20g/d), it is possible that fructose consuming individuals might not have spilt adequate quantities of fructose into the colon to properly induce and maintain CA. Moreover, there is to our knowledge no information on a possible prebiotic effect of the monosaccharide fructose. Since polymers of fructose are very good prebiotics it may be of interest to determine whether this sugar is capable of prebiotic function in its own right.
The investigators propose to carry out a short term study on 20-30 healthy participants to determine whether a 2 week period of fructose consumption alters clinical CA and intestinal microflora.
Study Outline After an overnight fast, except for water(ad libitum), participants present themselves to the GI lab around 9 am. A 50 gm fructose solution (this dose is associated with a 65% chance of maldigestion(14))will be administered. Breath hydrogen and symptoms will be recorded for 4.5 Hrs at ½ hr intervals. Participants will be asked to fill out a short 3 day diet recall questionnaire targeting fructose ingestion.
Participants will be asked to consume 30g fructose in 150ml of water (lemon juice may be added) twice a day for 14 days.They will then return for a repeat50 g fructose challenge. A small stool sample will be asked from participants at each test period.Another similar group will undergo the same tests but without taking intervening fructose.
- Conditions
- Healthy
- Being tested
- Fructose powder
- Keywords
- Fructose, Intolerance, Adaptation, Prebiotic, Healthy men or women 18-40
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose powderDietary supplement
30g in 250ml water twice a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 30g fructose dissolved in water twice a day Receives: Dietary Supplement: Fructose powder |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistically significant reduction in total sum breath hydrogen upon a 50g fructose challenge test.
Measured: intervention for 2 weeks per participant
Secondary outcomes (1)
A log 1 change in fecal bifidobacteria or lactobacilli species.
Measured: stools retested 2 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Andrew Szilagyi, MD, Principal investigator, SMBD Jewish General Hospital, McGill university School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775567
- Sponsor's protocol ID
- 07111
- Acronym
- MEF
- Status last verified
- Feb 2009
- First submitted
- 17 Oct 2008
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szilagyi A, Malolepszy P, Yesovitch S, Vinokuroff C, Nathwani U, Cohen A, Xue X. Fructose malabsorption may be gender dependent and fails to show compensation by colonic adaptation. Dig Dis Sci. 2007 Nov;52(11):2999-3004. doi: 10.1007/s10620-006-9652-9. Epub 2007 Mar 15.
PubMed 17357833Rao SS, Attaluri A, Anderson L, Stumbo P. Ability of the normal human small intestine to absorb fructose: evaluation by breath testing. Clin Gastroenterol Hepatol. 2007 Aug;5(8):959-63. doi: 10.1016/j.cgh.2007.04.008. Epub 2007 Jul 10.
PubMed 17625977Szilagyi A, Malolepszy P, Yesovitch S, Nathwani U, Vinokuroff C, Cohen A, Xue X. Inverse dose effect of pretest dietary lactose intake on breath hydrogen results and symptoms in lactase nonpersistent subjects. Dig Dis Sci. 2005 Nov;50(11):2178-82. doi: 10.1007/s10620-005-3028-4.
PubMed 16240236Briet F, Achour L, Flourie B, Beaugerie L, Pellier P, Franchisseur C, Bornet F, Rambaud JC. Symptomatic response to varying levels of fructo-oligosaccharides consumed occasionally or regularly. Eur J Clin Nutr. 1995 Jul;49(7):501-7.
PubMed 7588500
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Microbial and Clinical Adaptation to Large Doses of Fructose
- ClinicalTrials.gov ID
- NCT00775567
- Acronym / sponsor ID
- MEF / 07111
- Conditions
- Healthy
- Keywords
- Fructose, Intolerance, Adaptation, Prebiotic, Healthy men or women 18-40
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Oct 2008 (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.
Fructose is the principal carbohydrate in fruits and is added to many food products. This 6 carbon sugar is associated with a number of ill effects, like promotion of high triglycerides,precipitation of gout in men,possible depression in women and symptoms of intolerance in a non ethnic dose dependent fashion.However, high fruit and vegetable intake is associated with some epidemiologic evidence in prevention of some cancers like stomach and colorectum.The principal protectors in these products are thought to be antioxidants and other protective chemicals like polyphenols.In addition long chain polymers of fructose:inulin are thought to help protect against cancer through prebiotic effects. In fact poly-fructose molecules are used as prebiotic food supplements and are promoted as aids for a healthy intestine with "balanced microflora".
Polyfructose prebiotics induce some gastrointestinal symptoms of cramps gas bloating and sometimes diarrhea.To date repeated consumption of these polyfructose molecules have not been shown to induce colonic adaptation. Nor is there evidence that fructose intolerant people "adapt " to prolonged ingestion.
These findings are in contrast to findings with lactose intolerance where prolonged ingestion leads to both symptomatic and physiological adaptation.In this interventional study we evaluate whether fructose intolerant people can adapt to moderate dose daily fructose ingestion.The desired outcome is symptomatic, physiological and colonic microfloral adaptation. A failure to detect an increase in bifidobacteria on retesting may suggest that in humans like in some other mammals GLUT5 fructose transport could be induced.
Detailed description
The concept of Colonic Adaptation(CA) to regular carbohydrates has been linked mainly to lactose disaccharide(galactose,glucose) and lactulose(galactose, fructose), a manufactured derivative of lactose. CA is achieved in both cases by short term regular consumption of the targeted sugar which is not digested by the host. The clinical definition of CA includes a measured change in breath hydrogen, reduction of clinical symptoms (Bloat, gas, cramps and at times diarrhea) and an associated increase of bacterial lactase(β-galactosidase. The putative mechanism is through bacterial action which results in enhanced metabolism or expanded bacterial population of specific genus and species of bacteria. The act of CA may incur health benefits through physicochemical changes and especially promotion of health promoting bacteria.
Maldigestion of fructose occurs in the population probably in a dose dependent fashion. The sugar content overwhelms the principal GLUT5 intestinal carrier. In the presence of glucose this non energy dependent system works better(11). In a previous publication we found that the pre test graded ingestion of fructose had no impact on test results. These results were dramatically different from that found for pretest lactose ingestion. The investigators interpreted the results from the fructose study as being consistent with a failure to show CA to regular fructose consumption.
More recently Rao et al however, showed that there may be a threshold level of intake beyond which fructose maldigestion may rapidly increase. This value was thought to be 15-20g. In the case of lactose this was 10g(15). Since in both our studies we used the same dose response analysis(<10,11-19, and >20g/d), it is possible that fructose consuming individuals might not have spilt adequate quantities of fructose into the colon to properly induce and maintain CA. Moreover, there is to our knowledge no information on a possible prebiotic effect of the monosaccharide fructose. Since polymers of fructose are very good prebiotics it may be of interest to determine whether this sugar is capable of prebiotic function in its own right.
The investigators propose to carry out a short term study on 20-30 healthy participants to determine whether a 2 week period of fructose consumption alters clinical CA and intestinal microflora.
Study Outline After an overnight fast, except for water(ad libitum), participants present themselves to the GI lab around 9 am. A 50 gm fructose solution (this dose is associated with a 65% chance of maldigestion(14))will be administered. Breath hydrogen and symptoms will be recorded for 4.5 Hrs at ½ hr intervals. Participants will be asked to fill out a short 3 day diet recall questionnaire targeting fructose ingestion.
Participants will be asked to consume 30g fructose in 150ml of water (lemon juice may be added) twice a day for 14 days.They will then return for a repeat50 g fructose challenge. A small stool sample will be asked from participants at each test period.Another similar group will undergo the same tests but without taking intervening fructose.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Fructose powder30g fructose dissolved in water twice a day |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy participants
Key exclusion criteria (3 listed)
- Antibiotics 90 days pre entry
- Use of gastrointestinal motility drugs eg loperamide, metoclopramide significant fiber supplements
- Pregnancy
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 |
|---|---|---|
| Fructose powder30g in 250ml water twice a day | Dietary supplement | 1 |
Primary outcome
Statistically significant reduction in total sum breath hydrogen upon a 50g fructose challenge test.
Time frame: intervention for 2 weeks per participant
1 secondary outcome
A log 1 change in fecal bifidobacteria or lactobacilli species.
Time frame: stools retested 2 weeks apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
- Background: PubMed 17357833Szilagyi A, Malolepszy P, Yesovitch S, Vinokuroff C, Nathwani U, Cohen A, Xue X. Fructose malabsorption may be gender dependent and fails to show compensation by colonic adaptation. Dig Dis Sci. 2007 Nov;52(11):2999-3004. doi: 10.1007/s10620-006-9652-9. Epub 2007 Mar 15.
- Background: PubMed 17625977Rao SS, Attaluri A, Anderson L, Stumbo P. Ability of the normal human small intestine to absorb fructose: evaluation by breath testing. Clin Gastroenterol Hepatol. 2007 Aug;5(8):959-63. doi: 10.1016/j.cgh.2007.04.008. Epub 2007 Jul 10.
- Background: PubMed 16240236Szilagyi A, Malolepszy P, Yesovitch S, Nathwani U, Vinokuroff C, Cohen A, Xue X. Inverse dose effect of pretest dietary lactose intake on breath hydrogen results and symptoms in lactase nonpersistent subjects. Dig Dis Sci. 2005 Nov;50(11):2178-82. doi: 10.1007/s10620-005-3028-4.
- Background: PubMed 7588500Briet F, Achour L, Flourie B, Beaugerie L, Pellier P, Franchisseur C, Bornet F, Rambaud JC. Symptomatic response to varying levels of fructo-oligosaccharides consumed occasionally or regularly. Eur J Clin Nutr. 1995 Jul;49(7):501-7.
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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.
Andrew Szilagyi, MD principal investigator
SMBD Jewish General Hospital, McGill university School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose powder in people with Healthy, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 10 Aug 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistically significant reduction in total sum breath hydrogen upon a 50g fructose challenge test. (time frame: intervention for 2 weeks per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775567, which also lists 4 linked publications.
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 10 Aug 2011.