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Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance

Primary Purpose

Fructose Intolerance

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placedo
Alanine
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fructose Intolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
  • Women of childbearing potential must agree to a urine pregnancy test before supplement is dispensed and to avoid pregnancy throughout the study.

Exclusion Criteria:

  • Cognitive impairment or any other inability to provide informed consent
  • Prisoners
  • GI surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy
  • Antibiotics in the previous 6 weeks.
  • Major co-morbid illnesses, including chronic pancreatitis, celiac disease, inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc.
  • Medication use: opioids, Tegaserod, laxatives, enemas
  • Difficulty Swallowing
  • Known food allergies or intolerance to any fiber supplements or other dietary nutritional supplements such as: Psyllium (Metamucil), Maltodextrin, Citric Acid, and methylcellulose (Citrucel).

Sites / Locations

  • Augusta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Experimental Alanine

Arm Description

Psyllium powder is used as the placebo. A member of the research staff will package and dispense L-alanine and placebo in similar containers. A standard measuring spoon will be provided to the subject for preparing the placebo solution. Subjects will mix the placebo in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian. Meal Placebo Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops

L-alanine, USP (Spectrum® Chemicals and Laboratory Products, Gardena, CA) will be packaged and dispensed by one member of the research staff who will have no other role in the study. A one-month supply will be dispensed to the subjects. Meal L-Alanine Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops

Outcomes

Primary Outcome Measures

GI symptom score
Change in GI symptom score with alanine and placebo, when compared to the baseline

Secondary Outcome Measures

Fructose consumption
Estimated daily consumption of fructose during the alanine and placebo phases, when compared to the baseline using prospective food diaries
Breath hydrogen and methane
Changes in breath hydrogen and/or methane values with alanine and placebo when compared with to the baseline
Quality of Life (SF-12)
Changes in SF-12 scores between and after baseline and placebo

Full Information

First Posted
July 15, 2019
Last Updated
April 13, 2020
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT04022434
Brief Title
Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance
Official Title
Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance: a Double-blind, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2014 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Over the past few decades, fructose consumption has risen significantly in the United States1. This sugar is increasingly being used as a sweetener in a variety of foods1. Because there is a limited absorptive capacity for fructose, excessive ingestion of fructose leads to fructose malabsorption and dietary fructose intolerance (DFI) 2-9, 13. Incomplete absorption of fructose may lead to a variety of gastrointestinal symptoms, including bloating, pain, gas and diarrhea 2-9. In tertiary care centers, the prevalence of DFI in subjects with unexplained GI symptoms has been estimated to range between 11-50 %, when subjects were assessed with breath tests following administration of 25 grams of fructose 2, 5-7. Currently, the main treatment for DFI consists of restricting the intake of fructose-containing foods 10-12 or limiting the intake of foods with excess "free fructose" (ie, fructose in excess of glucose) or a high fructan content17. These diet restrictions can improve symptoms in patients with DFI 10-12,17. However, the diet is very restrictive and imposes a significant burden on the individual and the family. In one study, 40% of subjects were unable to comply with dietary restrictions 10. Currently, there are no other therapeutic agents for treating this condition 14, 15. Apart from promoting intestinal fructose absorption, an ideal therapeutic agent should be safe, simple to use, inexpensive and have no calorific value. Fructose is mostly absorbed in the small intestine by facilitated diffusion which is mediated by the GLUT-5 transporter protein. This protein is expressed on the intestinal mucosal surface. In the presence of glucose, fructose absorption is increased, mostly due to co-transport with glucose via the GLUT-2 transporter protein. However, the calorie content of glucose precludes its routine use in patients with DFI. Other compounds that promote fructose absorption, such as 3 O-methyl glucose and epidermal growth factor (EGF) have significant side effects and safety issues, making them unsuitable for clinical use in DFI. Several amino acids, including alanine, have been also been shown to increase intestinal fructose absorption 14. The postulated mechanism is as follows: transmucosal Na+-coupled amino acid transport causes increased water flow through the mucosal apical membrane14. This, in turn, facilitates fructose absorption by a process of 'solvent drag', caused by an increase in intraluminal fructose concentration caused by water removal from the lumen14. The potential benefit of alanine was assessed in a European study in healthy children 14. Ten subjects underwent H2 breath tests following administration of fructose alone (2g/ Kg body weight), followed by a combination of fructose and an equi-molar dose of various amino acids (L-alanine, L-phenylalanine, L-glutamine, L-proline) or glucose. Breath H2 production was assessed as a marker of intestinal fructose absorption. Subjects were asked to report any gastrointestinal symptoms during the test. All subjects had a positive (>20 ppm of H2) breath test (68 ± 38 ppm) with fructose and 6/10 subjects reported either abdominal pain or diarrhea during the test. Co-administration of alanine caused a significant (p < 0.05) decrease in breath H2 production (3 ± 3 ppm), suggesting increased intestinal fructose absorption. Furthermore, none of the subjects reported any gastrointestinal symptoms during the test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fructose Intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Psyllium powder is used as the placebo. A member of the research staff will package and dispense L-alanine and placebo in similar containers. A standard measuring spoon will be provided to the subject for preparing the placebo solution. Subjects will mix the placebo in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian. Meal Placebo Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops
Arm Title
Experimental Alanine
Arm Type
Experimental
Arm Description
L-alanine, USP (Spectrum® Chemicals and Laboratory Products, Gardena, CA) will be packaged and dispensed by one member of the research staff who will have no other role in the study. A one-month supply will be dispensed to the subjects. Meal L-Alanine Breakfast * 1-2 scoops Snack * .5 - 1 scoop Lunch * 1-2 scoops Snack * .5 - 1 scoop Dinner * 1-2 scoops
Intervention Type
Dietary Supplement
Intervention Name(s)
Placedo
Intervention Description
Subjects will mix the placebo in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.
Intervention Type
Dietary Supplement
Intervention Name(s)
Alanine
Intervention Description
Subjects will mix the alanine in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.
Primary Outcome Measure Information:
Title
GI symptom score
Description
Change in GI symptom score with alanine and placebo, when compared to the baseline
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fructose consumption
Description
Estimated daily consumption of fructose during the alanine and placebo phases, when compared to the baseline using prospective food diaries
Time Frame
4 weeks
Title
Breath hydrogen and methane
Description
Changes in breath hydrogen and/or methane values with alanine and placebo when compared with to the baseline
Time Frame
4 weeks
Title
Quality of Life (SF-12)
Description
Changes in SF-12 scores between and after baseline and placebo
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Women of childbearing potential must agree to a urine pregnancy test before supplement is dispensed and to avoid pregnancy throughout the study. Exclusion Criteria: Cognitive impairment or any other inability to provide informed consent Prisoners GI surgery except appendectomy, cholecystectomy, caesarean section, hysterectomy Antibiotics in the previous 6 weeks. Major co-morbid illnesses, including chronic pancreatitis, celiac disease, inflammatory bowel disease, diabetes, scleroderma, pseudo-obstruction syndromes etc. Medication use: opioids, Tegaserod, laxatives, enemas Difficulty Swallowing Known food allergies or intolerance to any fiber supplements or other dietary nutritional supplements such as: Psyllium (Metamucil), Maltodextrin, Citric Acid, and methylcellulose (Citrucel).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satish Rao, MD
Phone
7067211968
Email
srao@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Smith
Phone
7067211968
Email
hsmith@augusta.edu
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satish Rao, MD
Phone
706-721-1968
Email
srao@augusta.edu
First Name & Middle Initial & Last Name & Degree
Helen Smith
Phone
7067211968
Email
hsmith@augusta.edu

12. IPD Sharing Statement

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Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance

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