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Carbohydrate IntoleranceNCT06057376

Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

A study testing Low-FODMAP diet group (LFD) and Low Sugar diet group (LAS) in people with Carbohydrate Intolerance, run by Oregon Health and Science University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Carbohydrate Intolerance
What is being tested?
Low-FODMAP diet group (LFD) and Low Sugar diet group (LAS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
26 Oct 2023to Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Use of oral or IV antibiotics in the last three months
  • Daily probiotic use (pill form)
  • Daily multi-vitamin except vitamin D supplements

Trial locations and contacts

1 site in 1 country.

Anna Hunter, MD contact

(503) 494-1098

huntean@ohsu.edu

Deepannita Roy, MPH contact

503-494-8344

royde@ohsu.edu

United States1 site, 1 recruiting
  • Oregon Health and Science University

    Springfield, Oregon, 97477

    Anna Hunter, MD, 503-494-1098, huntean@ohsu.edu

    Recruiting

Other trials in United States

About this study

Official title: Clinical Comparison of the Impact of Two Dietary Interventions on Abdominal Pain and Intestinal Microbiome Caused by Simple Carbohydrate Intolerance.

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.

Read the 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.

Being tested
Low-FODMAP diet group (LFD), Low Sugar diet group (LAS)
Medical subject headings
Glucose-Galactose Malabsorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-FODMAP diet group (LFD)Other

    Each participant will be following a low-FODMAP diet group for 3 weeks, followed by 3 week break prior to second diet intervention.

  • Low Sugar diet group (LAS)Other

    Each participant will be following a low added sugar diet group for 3 weeks, after 3 week break.

Study groups in NCT06057376
Study groupRoleWhat they receive
Low FODMAP groupOtherParticipants 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.
Receives: Other: Low-FODMAP diet group (LFD)
Low Added Sugar groupOtherEach 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.
Receives: Other: Low Sugar diet group (LAS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Abdominal Pain

    Diet impact on abdominal pain as assessed by a questionnaire before and after each diet intervention

    Measured: 63 days

  2. 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

    Measured: 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start26 Oct 2023
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057376
Sponsor's protocol ID
IRB No.24928
Status last verified
Apr 2024
First submitted
15 Sep 2023
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Low-FODMAP diet group (LFD) and Low Sugar diet group (LAS) in people with Carbohydrate Intolerance, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Hunter, MD ((503) 494-1098, huntean@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal Pain (time frame: 63 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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