Trial record 3 of 4 for:    "hereditary fructose intolerance" OR "Fructose Metabolism, Inborn Errors" OR "Fructose Intolerance"

Long Term Fructose

This study has been terminated.
(PI moved institutions and changed study protocol)
Sponsor:
Information provided by (Responsible Party):
Satish Rao, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01288495
First received: January 31, 2011
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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 Intervention
Dietary Fructose Intolerance
Dietary Supplement: supplemental L-alanine
Dietary Supplement: Metamucil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance: a Double-blind, Randomized Crossover Study

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • GI symptom score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in GI symptom score with alanine & placebo, when compared to the baseline


Secondary Outcome Measures:
  • Fructose consumption [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Estimated daily consumption of fructose during the alanine & placebo phases, when compared to baseline


Enrollment: 15
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288495

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

No publications provided

Responsible Party: Satish Rao, PI, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01288495     History of Changes
Other Study ID Numbers: Long Term Fructose
Study First Received: January 31, 2011
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fructose Intolerance
Carbohydrate Metabolism, Inborn Errors
Fructose Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on October 29, 2014