Investigation of Alanine in Fructose Intolerance: A Dose Ranging Study

NCT ID: NCT01185210

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2024-04-30

Brief Summary

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.

Conditions

Fructose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Subjects will receive placebo (mix of sugar and salt).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Subjects will receive placebo (mix of sugar and salt) 20 minutes before consuming fructose.

Alanine - 12.5

Subjects will receive 12.5 grams of alanine

Group Type: EXPERIMENTAL

Alanine

Intervention Type: DIETARY_SUPPLEMENT

Subjects will receive 12.5 grams of alanine 20 minutes before consuming fructose.

Alanine - 25

Subjects will receive 25 grams of alanine.

Group Type: EXPERIMENTAL

Alanine

Intervention Type: DIETARY_SUPPLEMENT

Subjects will receive 25 grams of alanine 20 minutes before consuming fructose.

Interventions

Placebo

Subjects will receive placebo (mix of sugar and salt) 20 minutes before consuming fructose.

Intervention Type: DIETARY_SUPPLEMENT

Alanine

Subjects will receive 12.5 grams of alanine 20 minutes before consuming fructose.

Intervention Type: DIETARY_SUPPLEMENT

Alanine

Subjects will receive 25 grams of alanine 20 minutes before consuming fructose.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

Teikyo University

OTHER

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Satish Rao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Satish Rao, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Satish SC Rao, MD

Role: CONTACT

satish-rao@uiowa.edu

319-353-6602

Facility Contacts

Satish SC Rao, MD

Role: primary

satish-rao@uiowa.edu

319-353-6602

Other Identifiers

Fructose: Double Blind

Identifier Type: -

Identifier Source: org_study_id