Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

NCT06057376 | Recruiting

• 1 other identifier: IRB No.24928
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Carbohydrate Intolerance

Outcome Measures

Primary Outcomes (2)

• Abdominal Pain

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

  63 days

• 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

  63 days

Study Arms (2)

Low FODMAP group

OTHER

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.

Other: Low-FODMAP diet group (LFD)

Low Added Sugar group

OTHER

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.

Other: Low Sugar diet group (LAS)

Interventions

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 FODMAP group

Low Sugar diet group (LAS) OTHER

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

Low Added Sugar group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Oregon: collaborator
• Oregon State University: collaborator

Study Sites (1)

Oregon Health and Science University

Springfield, Oregon, 97477, United States

RECRUITING

MeSH Terms

Conditions

Glucose-Galactose Malabsorption

Interventions

lipoic acid synthase

Study Officials

• Anna Hunter, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Hunter, MD

CONTACT

(503) 494-1098; huntean@ohsu.edu

Deepannita Roy, MPH

CONTACT

503-494-8344; royde@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: October 26, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

US (1)