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Trial record 3 of 3 for:    "Acquired fructose intolerance"

Long Term Fructose

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ClinicalTrials.gov Identifier: NCT01288495
Recruitment Status : Terminated (PI moved institutions and changed study protocol)
First Posted : February 2, 2011
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Data suggest that alanine may facilitate the intestinal absorption of fructose in patients with DFI and thereby may decrease GI symptoms.

We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks that contain foods with free fructose or high fructose content will decrease GI symptoms in subjects with dietary fructose intolerance by facilitating intestinal absorption of fructose.

Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a randomized, double blind, cross over study.

Methods: We propose to investigate the effects of co-administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose intolerance, in a randomized, double blind, cross over study.

Data Analysis: The primary outcome measure will be a comparison of baseline breath sample values and study visit breath sample values. Additionally, we will assess subject-reported occurence and severity of nine gastrointestinal symptoms during the test on a visual analog scale (VAS).

Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will improve with ingestion of supplemental L-alanine (along with foods containing free fructose or high fructose content). We additionally expect treatment of DFI with administration of L-alanine powder to be more practical than co-ingestion of alanine-rich foods, and more convenient for patients.


Condition or disease Intervention/treatment
Dietary Fructose Intolerance Dietary Supplement: supplemental L-alanine Dietary Supplement: Metamucil

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance: a Double-blind, Randomized Crossover Study
Study Start Date : February 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: L-alanine
Subjects will consume l-alanine prior to eating fructose-containing foods.
Dietary Supplement: supplemental L-alanine
Subjects will consume l-alanine prior to eating fructose-containing foods.
Placebo Comparator: Placebo
Subjects will consume the placebo prior to eating fructose-containing foods.
Dietary Supplement: Metamucil
Subjects will consume the placebo prior to eating fructose-containing foods.


Outcome Measures

Primary Outcome Measures :
  1. GI symptom score [ Time Frame: 8 weeks ]
    Change in GI symptom score with alanine & placebo, when compared to the baseline


Secondary Outcome Measures :
  1. Fructose consumption [ Time Frame: 8 weeks ]
    Estimated daily consumption of fructose during the alanine & placebo phases, when compared to baseline


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18-99 years
  2. Diagnosis of fructose malabsorption (positive breath test after ingestion of 25 grams of fructose defined as either (a) ≥ 20 ppm rise of breath H2/CH4/both over baseline values or a successive rise of ≥ 5 ppm over baseline and in 3 consecutive breath samples)

Exclusion Criteria:

  1. Cognitive impairment or any other inability to provide informed consent
  2. Prisoners
  3. GI surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy
  4. Antibiotics in the previous 6 weeks
  5. History of bacterial overgrowth or lactose intolerance
  6. Major co-morbid illnesses, including chronic pancreatitis, celiac disease, inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc.
  7. Known food allergies
  8. Medication use: opioids, Tegaserod, laxatives, enemas
  9. An allergy or intolerance to any fiber supplements or other dietary nutritional supplements such as: psyllium (Metamucil), Maltodextrin, Citric Acid, and methylcellulose (Citrucel).
  10. Difficulty swallowing
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288495


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Augusta University
More Information

Responsible Party: Satish Rao, PI, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01288495     History of Changes
Other Study ID Numbers: Long Term Fructose
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Fructose Intolerance
Fructose Metabolism, Inborn Errors
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Psyllium
Cathartics
Gastrointestinal Agents