Investigation of Alanine in Fructose Intolerance: A Dose Ranging Study
| Status: | Recruiting |
|---|---|
| Conditions: | Metabolic |
| Therapuetic Areas: | Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 7/25/2018 |
| Start Date: | September 2007 |
| End Date: | December 31, 2018 |
| Contact: | Satish SC Rao, MD |
| Email: | satish-rao@uiowa.edu |
| Phone: | 319-353-6602 |
Investigation of Alanine in Fructose Intolerance: A Randomized, Double Blind, Dose Ranging, Placebo Controlled Study
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.
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.
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
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
Phone: 319-353-6602
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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