Effect of Fructose on Colonic Microflora

NCT00775567 | Completed DMC

• 1 other identifier: 07111
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Healthy

Keywords

Fructose; Intolerance; Adaptation; Prebiotic; Healthy men or women 18-40

Outcome Measures

Primary Outcomes (1)

• Statistically significant reduction in total sum breath hydrogen upon a 50g fructose challenge test.

  intervention for 2 weeks per participant

Secondary Outcomes (1)

• A log 1 change in fecal bifidobacteria or lactobacilli species.

  stools retested 2 weeks apart

Study Arms (2)

1

ACTIVE COMPARATOR

30g fructose dissolved in water twice a day

Dietary Supplement: Fructose powder

No Intervention

NO INTERVENTION

Interventions

Fructose powder DIETARY_SUPPLEMENT

30g in 250ml water twice a day

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants

You may not qualify if:

• Antibiotics 90 days pre entry
• Use of gastrointestinal motility drugs eg loperamide, metoclopramide significant fiber supplements
• Pregnancy

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

SMBD Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (4)

• 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.

  PMID: 17357833 BACKGROUND

• Rao 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.

  PMID: 17625977 BACKGROUND

• Szilagyi 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.

  PMID: 16240236 BACKGROUND

• Briet 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.

  PMID: 7588500 BACKGROUND

Related Links

• Full article on line

Study Officials

• Andrew Szilagyi, MD

  SMBD Jewish General Hospital, McGill university School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 10, 2011

Record last verified: 2009-02

Locations

CA (1)