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Behavioural Intervention

Dietary Interventions for Carbohydrate Intolerance

N/A

Recruiting

Led By Anna Hunter, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI: within normal range for age

Age: 5-18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 63 days

Awards & highlights

Study Summary

This trial will compare two diets to see which is more effective at reducing abdominal pain caused by simple sugar intolerance. It will also measure the impact of the diets on the microbiome.

Who is the study for?

This trial is for kids and teens aged 5-18 with normal BMI who experience abdominal pain due to simple sugar intolerance, as shown by a positive fructose breath test. They must be willing to follow specific diets (low FODMAP or low added sugars) and provide samples. It's not for those with intestinal disorders like IBD, food allergies, or significant dietary restrictions.Check my eligibility

What is being tested?

The study compares the effects of two diets on abdominal pain caused by sugar intolerance: one group follows a Low-FODMAP diet while the other eliminates added sugars. The impact on gut bacteria and their products will also be assessed.See study design

What are the potential side effects?

Potential side effects from these dietary changes may include initial discomfort such as bloating or constipation as the body adjusts to new eating habits. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is within the normal range for my age.

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I am between 5 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 63 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~63 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Abdominal Pain

Effect of each diet on microbiome and metabolome

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low FODMAP groupExperimental Treatment1 Intervention

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.

Group II: Low Added Sugar groupExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,872 Total Patients Enrolled

University of OregonOTHER

80 Previous Clinical Trials

46,866 Total Patients Enrolled

Oregon State UniversityOTHER

50 Previous Clinical Trials

8,401 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for the experimental protocol?

"Applicants of this medical experiment must be within the age group of 5 to 18 years old in order to qualify."

Answered by AI

Are there opportunities for qualified participants to join the current clinical trial?

"According to clinicaltrials.gov, this medical trial is actively recruiting participants right now. The study was first unveiled on October 1st 2023 and modified for the last time on September 21st 2023."

Answered by AI

Is there an opportunity to partake in this research trial?

"Candidates with carbohydrate intolerance aged between 5 and 18 are eligible for this experimental trial, which seeks to enroll 40 participants."

Answered by AI

How many individuals are involved in this experiment?

"Affirmative. Clinicaltrials.gov's records show that this clinical trial, which was initially posted on October 1st 2023, is actively enrolling participants. 40 people are required to take part in the study and it will be conducted at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance

Anna Hunter, MD, MCR 2023. "Impact of Two Dietary Interventions on Simple Carbohydrate Intolerance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06057376.