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Investigation of Alanine in Fructose Intolerance: A Dose Ranging Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185210
First Posted: August 19, 2010
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Iowa
Teikyo University
Information provided by (Responsible Party):
Satish Rao, Augusta University
  Purpose

Background:

Over the past few decades, fructose is increasingly being used as a sweetener/ additive in a variety of foods. Incomplete absorption of fructose has been implicated as a cause of gastrointestinal symptoms. In tertiary care centers, the prevalence of fructose malabsorption in subjects with unexplained GI symptoms is thought to be between 11-50%, when assessed with breath tests following administration of 25 grams of fructose in a 10% solution. Restriction of dietary fructose has been shown to improve symptoms in these patients to an extent. Currently, there are no therapeutic agents that improve intestinal fructose absorption and thereby decrease symptoms. Studies in the pediatric population have shown that fructose absorption in the small intestine is increased in the presence of glucose or amino acids, especially alanine.

Objective:

The investigators' objective is to assess whether co-administration of an oral solution of L-alanine facilitates fructose absorption and decreases gastrointestinal (GI) symptoms associated with fructose malabsorption in subjects undergoing standard fructose breath test when compared to placebo.

Methods and analysis:

The investigators propose a randomized, double-blind study in 40 subjects with known fructose intolerance. After an overnight fast, each subject will receive an oral solution of 12.5 grams of alanine in 125cc of water or placebo. Next, the subject will receive an oral solution of 25 grams of fructose in a 10% solution. Serum, urine and breath samples will be collected at baseline and at 30-minute intervals for 4 hours. GI symptoms will also be assessed and recorded at 30 minute intervals using a standard questionnaire. Repeated measures ANOVA will be used to compare the data obtained during the study protocol with the baseline (pre-study) data.

Expected outcomes:

Co-administration of alanine with fructose may improve fructose absorption and decrease symptoms in subjects with fructose intolerance.

Hypothesis: Ingestion of alanine along with fructose, will facilitate intestinal absorption of fructose in subjects with fructose malabsorption.

Aim: To investigate the effects of co-administration of equi-molar doses of alanine on a) the absorption of fructose and b) the occurrence of GI symptoms in subjects with fructose malabsorption.


Condition Intervention
Fructose Intolerance Dietary Supplement: Placebo Dietary Supplement: Alanine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Alanine in Fructose Intolerance: A Randomized, Double Blind, Dose Ranging, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Satish Rao, Augusta University:

Primary Outcome Measures:
  • Decrease breath Hydrogen and/or Methane production [ Time Frame: less than 6 months ]

Secondary Outcome Measures:
  • Occurrence or severity of GI symptoms during the test [ Time Frame: less than 6 months ]

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will receive placebo (mix of sugar and salt).
Dietary Supplement: Placebo
Subjects will receive placebo (mix of sugar and salt) 20 minutes before consuming fructose.
Experimental: Alanine - 12.5
Subjects will receive 12.5 grams of alanine
Dietary Supplement: Alanine
Subjects will receive 12.5 grams of alanine 20 minutes before consuming fructose.
Experimental: Alanine - 25
Subjects will receive 25 grams of alanine.
Dietary Supplement: Alanine
Subjects will receive 25 grams of alanine 20 minutes before consuming fructose.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18-70 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 3 months
  5. 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. Diabetes
  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): NCT01185210


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Augusta University
University of Iowa
Teikyo University
Investigators
Principal Investigator: Satish Rao, Md, PhD University of Iowa
  More Information

Responsible Party: Satish Rao, Professor, Augusta University
ClinicalTrials.gov Identifier: NCT01185210     History of Changes
Other Study ID Numbers: Fructose: Double Blind
First Submitted: September 22, 2009
First Posted: August 19, 2010
Last Update Posted: July 13, 2017
Last Verified: July 2017

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