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Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

Primary Purpose

Carbohydrate Intolerance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-FODMAP diet group (LFD)
Low Sugar diet group (LAS)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carbohydrate Intolerance

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 5- 18-year-old BMI: within normal range for age Positive fructose breath test performed as part of diagnostic work up for abdominal pain Willingness to consume low FODMAP and Limited Added sugar diet trial and collect required samples Exclusion Criteria: Age: not within range BMI: not within range Negative fructose breath test Any known or suspected intestinal disorder including but not limited to IBD, IBS, celiac disease, Crohn's Disease, food sensitivities, food allergies, significant by-choice food restrictions Hormonal disorders Use of chronic medications including contraceptives (both oral and subcutaneous), non-hormone secreting IUD- accepted Use of oral or IV antibiotics in the last three months Daily probiotic use (pill form) Daily multi-vitamin except vitamin D supplements

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low FODMAP group

Low Added Sugar group

Arm Description

Participants randomized to this group will be instructed based on published low-FODMAP diet guidelines and provided with sample meal plans to aid in compliance. Each participant will be randomized to low-FODMAP diet group (LFD) for 3 weeks.

Each participant will be randomized to either the low-FODMAP diet group (LFD) or the low added sugar diet group (LAS) for 3 weeks. Each participant will be randomized to the low added sugar diet group (LAS) for 3 weeks.

Outcomes

Primary Outcome Measures

Abdominal Pain
Diet impact on abdominal pain as assessed by a questionnaire before and after each diet intervention
Effect of each diet on microbiome and metabolome
Impact of each diet intervention on microbiome and metabolome will be assessed utilizing a stool sample collected prior to and after diet completion

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
September 21, 2023
Sponsor
Oregon Health and Science University
Collaborators
University of Oregon, Oregon State University
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1. Study Identification

Unique Protocol Identification Number
NCT06057376
Brief Title
Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance
Official Title
Clinical Comparison of the Impact of Two Dietary Interventions on Abdominal Pain and Intestinal Microbiome Caused by Simple Carbohydrate Intolerance.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
University of Oregon, Oregon State 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
In this project we want to assess impact of dietary fructose as a simple sugar intolerance on abdominal pain and compare a low FODMAP diet versus an added sugar elimination diet effectiveness on symptoms but also impact on microbiome and its metabolome.
Detailed Description
This is a prospective cross over study. Participants who meet the study entry criterion, will be randomized to a specific dietary intervention: low FODMAP for a 3-week period or Limited Added Sugar for 3 weeks. After the initial study phase, participants will enter a 3 week break followed by a crossover to the other diet phase. Each participant will be randomized to either the low-FODMAP diet group (LFD) or the low added sugar diet group (LAS) for 3 weeks. All participants will be assigned to a nutrition intervention consisting of 2 one-hour counseling sessions (pre and post diet initiation) plus one 30 min telephone session at week 1 and 2 of the intervention for both diet groups. Macronutrients will not be restricted and both study diets will be ad libitum. Diet interventions will include administration of a 24 hour food recall and completion of the Comprehensive Nutrition Assessment Questionnaire in addition to comprehensive education of the assigned diet. Investigators will collect stool samples prior to intervention and post each diet intervention to assess initial microbiome composition as well as post intervention changes. Symptom data will be collected via an online survey link consisting of abdominal pain related questionnaires. Measures for child and parent will be requested at the time enrollment of the study and at the end of each diet phase. Animal studies indicate microbiome adjustment to an increase in dietary carbohydrate pool. It is difficult to capture this change in humans as the microbiome shift may not be evident by actual change in certain strains but by genomic adjustment. Investigators propose a metagenomic approach in combination with metabolomics to identify microbiome end products present as a result of changes in dietary carbohydrate intake by dietary elimination. Investigators will characterize shifts in metagenomic composition in response to dietary shifts using multivariate methods and linear mixed effects models. To address our hypothesis that FODMAP and low added sugar diets will affect microbial gene content in similar ways, investigators will compare metagenomic shifts relative to a baseline diet using multivariate models that control for subject, age, sex, diet order and potential confounding factors in PerMANOVA and distance-based redundancy analyses. Investigators will have 95% power to detect medium shifts in metabolic profiles among dietary groups (Cohen's D = 0.520). Investigators will use mixed effect linear models to measure enrichment for specific metabolic pathways and diet-driven shifts in specific metabolites over time while controlling for subject, age, sex, diet order, symptoms and potential confounding factors. In these repeated measures design, we will have 95% power to detect a small to medium effect of diet on a given metabolite (Cohen's D = 0.371). The Benhamini-Hochberg procedure will be applied to decrease the false discovery rate when running multiple tests (Yoav et al) It is also of interest to analyze how microbial gene content and metabolic profiles covary. Investigators will apply qualitative genetic methods of covariance matrix estimation to determine how metabolite profiles can be predicted by metagenomic content.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low FODMAP group
Arm Type
Other
Arm Description
Participants randomized to this group will be instructed based on published low-FODMAP diet guidelines and provided with sample meal plans to aid in compliance. Each participant will be randomized to low-FODMAP diet group (LFD) for 3 weeks.
Arm Title
Low Added Sugar group
Arm Type
Other
Arm Description
Each participant will be randomized to either the low-FODMAP diet group (LFD) or the low added sugar diet group (LAS) for 3 weeks. Each participant will be randomized to the low added sugar diet group (LAS) for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Low-FODMAP diet group (LFD)
Intervention Description
Each participant will be following a low-FODMAP diet group for 3 weeks, followed by 3 week break prior to second diet intervention.
Intervention Type
Other
Intervention Name(s)
Low Sugar diet group (LAS)
Intervention Description
Each participant will be following a low added sugar diet group for 3 weeks, after 3 week break.
Primary Outcome Measure Information:
Title
Abdominal Pain
Description
Diet impact on abdominal pain as assessed by a questionnaire before and after each diet intervention
Time Frame
63 days
Title
Effect of each diet on microbiome and metabolome
Description
Impact of each diet intervention on microbiome and metabolome will be assessed utilizing a stool sample collected prior to and after diet completion
Time Frame
63 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 5- 18-year-old BMI: within normal range for age Positive fructose breath test performed as part of diagnostic work up for abdominal pain Willingness to consume low FODMAP and Limited Added sugar diet trial and collect required samples Exclusion Criteria: Age: not within range BMI: not within range Negative fructose breath test Any known or suspected intestinal disorder including but not limited to IBD, IBS, celiac disease, Crohn's Disease, food sensitivities, food allergies, significant by-choice food restrictions Hormonal disorders Use of chronic medications including contraceptives (both oral and subcutaneous), non-hormone secreting IUD- accepted Use of oral or IV antibiotics in the last three months Daily probiotic use (pill form) Daily multi-vitamin except vitamin D supplements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Hunter, MD
Phone
(503) 494-1098
Email
huntean@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deepannita Roy, MPH
Phone
503-494-8344
Email
royde@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Hunter, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Hunter, MD
Phone
503-494-1098
Email
huntean@ohsu.edu

12. IPD Sharing Statement

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Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

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