Dietary Interventions for Carbohydrate Intolerance

Overseen By Deepannita Roy, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Antibiotics, Probiotics, Multivitamins

Disqualifiers: Intestinal disorders, Hormonal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different diets affect stomach pain in children with carbohydrate intolerance, specifically focusing on fructose. Participants will follow either a low-FODMAP diet, which limits certain hard-to-digest carbohydrates, or a diet that eliminates added sugars (Low Sugar diet). Researchers seek to identify which diet alleviates symptoms more effectively and how it impacts gut health. Children with frequent stomach pain who have tested positive for fructose intolerance may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on children's health.

Will I have to stop taking my current medications?

The trial excludes participants who use chronic medications, except for certain contraceptives and vitamin D supplements. If you are on other chronic medications, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that many people find the low-FODMAP diet easy to follow, often reducing stomach pain in those with IBS (irritable bowel syndrome). Some studies suggest it can ease IBS symptoms, but it doesn't work for everyone. About 25% of people might not see any improvement. Importantly, there are no major reports of serious side effects from this diet.

Similarly, studies on low-sugar diets have shown they can improve insulin use and lower blood sugar levels. People on these diets often lose weight and have lower triglyceride levels (a type of fat in the blood) within a few months. Low-sugar diets are generally considered safe, with no significant negative effects reported.

Both diets have been researched and are considered safe for most people. However, since everyone is different, paying attention to individual reactions and consulting a healthcare provider if needed is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dietary interventions for carbohydrate intolerance because they offer a personalized approach to managing symptoms. The Low-FODMAP diet (LFD) is distinct because it reduces specific short-chain carbohydrates that can be tough to digest, potentially easing bloating and discomfort. On the other hand, the Low Added Sugar diet (LAS) focuses on cutting down sugar intake, which may help manage blood sugar levels and improve gut health. These approaches are different from typical treatments that often rely on medication or general dietary advice, offering more targeted and potentially effective strategies for individuals struggling with carbohydrate intolerance.

What evidence suggests that this trial's dietary interventions could be effective for carbohydrate intolerance?

Research has shown that the low-FODMAP diet, which participants in this trial may follow, can reduce stomach issues in people with conditions like irritable bowel syndrome (IBS). This diet works by eliminating certain carbohydrates that cause bloating and pain. Meanwhile, the low-sugar diet, another option in this trial, can improve the body's insulin use, which is crucial for managing blood sugar levels. It also reduces the liver's sugar processing, potentially leading to better overall health. This trial studies both diets to assess their effectiveness in alleviating symptoms of carbohydrate intolerance, particularly stomach pain. ^{1 3 5 6 7}

Who Is on the Research Team?

Anna Hunter, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My BMI is within the normal range for my age.

You have a positive fructose breath test as part of diagnosing abdominal pain.

Willingness to consume low FODMAP and Limited Added sugar diet trial and collect required samples

Exclusion Criteria

Your weight is not in the right range for your height.

I have a hormonal disorder.

I use chronic medications or contraceptives, including non-hormone IUDs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention Phase 1

Participants are randomized to either the low-FODMAP diet or the low added sugar diet for 3 weeks

3 weeks

2 in-person counseling sessions, 1 telephone session per week

Washout Period

Participants undergo a 3-week break before crossing over to the other diet phase

3 weeks

Dietary Intervention Phase 2

Participants crossover to the other diet group for another 3 weeks

3 weeks

2 in-person counseling sessions, 1 telephone session per week

Follow-up

Participants are monitored for changes in microbiome and metabolome, and abdominal pain is assessed

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-FODMAP diet group (LFD)
• Low Sugar diet group (LAS)

Trial Overview

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.

How Is the Trial Designed?

Group I: Low FODMAP group Experimental Treatment 1 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 group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Oregon State University

Collaborator

Trials

51

Recruited

8,300+

Published Research Related to This Trial

In a 2-year study involving 61 adults with Type 2 diabetes, both low-fat and low-carbohydrate diets resulted in similar weight loss, but only the low-carbohydrate diet (LCD) led to significant improvements in health-related quality of life (HRQoL) after 12 months.

Participants on the LCD experienced notable enhancements in physical function, bodily pain, and general health scores, while those on the low-fat diet (LFD) showed no changes in HRQoL despite comparable weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomization to a low-carbohydrate diet advice improves health related quality of life compared with a low-fat diet at similar weight-loss in Type 2 diabetes mellitus. Guldbrand, H., Lindström, T., Dizdar, B., et al.[2022]

In the DIETFITS trial, which included 609 participants aged 18-50 over 12 months, both a healthy low-carbohydrate diet and a healthy low-fat diet led to significant weight loss, primarily driven by reductions in glycemic load rather than fat intake or total calories.

The study found that carbohydrate intake metrics, particularly the triglyceride/HDL cholesterol ratio, were strong predictors of weight loss, especially in individuals with high insulin secretion, supporting the carbohydrate-insulin model of obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the carbohydrate-insulin model in a reanalysis of the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial. Soto-Mota, A., Pereira, MA., Ebbeling, CB., et al.[2023]

A 3-day low-carbohydrate/high-fat diet (LC/HFD) led to significantly higher postprandial plasma glucose levels in nine healthy young men compared to a normal diet, indicating potential risks for developing type 2 diabetes.

The LC/HFD also resulted in increased levels of the incretin GLP-1 and a decrease in first-phase insulin secretion, suggesting that this dietary approach may negatively affect glucose regulation in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term low carbohydrate/high-fat diet intake increases postprandial plasma glucose and glucagon-like peptide-1 levels during an oral glucose tolerance test in healthy men. Numao, S., Kawano, H., Endo, N., et al.[2022]

Low-carbohydrate diets have shown positive results in treating diabetes, pre-diabetes, metabolic syndrome, and obesity, with evidence from randomized trials and meta-analyses indicating they are safe and effective for improving health outcomes in diabetic patients.

These diets can lead to significant benefits such as weight loss, reduced medication needs, and even remission in some cases of type 2 diabetes, although they are not yet widely recognized in Czech diabetology due to ongoing safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. Krejčí, H., Vyjídák, J., Kohutiar, M.[2019]

In a study of 48 children with intractable epilepsy, all three types of ketogenic diets (classical, MCT, and modified Atkins) were found to be comparably effective in reducing seizures, with 73% of participants experiencing a reduction of 50% or more in seizure frequency over two years.

The modified Atkins diet had lower rates of side effects compared to the other diets, and potassium citrate supplementation was effective in preventing kidney stones (nephrolithiasis) in patients on these diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-year single-center experience of the ketogenic diet: factors influencing efficacy, tolerability, and compliance. Wibisono, C., Rowe, N., Beavis, E., et al.[2017]

In a randomized controlled trial involving 30 patients with type 1 diabetes and subclinical celiac disease, a gluten-free diet (GFD) led to a significant reduction in the mean number of hypoglycemic episodes per month, decreasing from 3.5 at baseline to 2.3 at six months (P = .03).

The GFD group also showed improved glycemic control, with a mean decline in HbA1c of 0.73%, while the non-GFD group experienced an increase of 0.99% by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EFFECT OF GLUTEN-FREE DIET ON METABOLIC CONTROL AND ANTHROPOMETRIC PARAMETERS IN TYPE 1 DIABETES WITH SUBCLINICAL CELIAC DISEASE: A RANDOMIZED CONTROLLED TRIAL. Kaur, P., Agarwala, A., Makharia, G., et al.[2022]

A low FODMAP diet (LFD) significantly reduced IBS severity and improved symptoms like abdominal pain and bloating compared to a less restrictive low lactose diet (LLD) in a study of 29 IBS patients.

Both diets were effective in lowering IBS severity scores, but patients on the LFD reported greater symptom relief, indicating that while both diets are beneficial, the LFD may offer more targeted relief for specific IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment efficacy of a low FODMAP diet compared to a low lactose diet in IBS patients: A randomized, cross-over designed study. Krieger-Grübel, C., Hutter, S., Hiestand, M., et al.[2021]

In a 2-year study involving 61 adults with type 2 diabetes, both low-fat and low-carbohydrate diets resulted in similar weight loss, with maximum weight loss occurring at 6 months (LFD: -3.99 kg, LCD: -4.31 kg).

The low-carbohydrate diet led to significant reductions in HbA(1c) levels and insulin doses at 6 months, indicating better glycemic control and potential cardiovascular safety compared to the low-fat diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss. Guldbrand, H., Dizdar, B., Bunjaku, B., et al.[2022]

A low FODMAP diet (LFD) significantly reduced symptoms in patients with irritable bowel syndrome (IBS) after six weeks, with most patients understanding the dietary guidelines provided by their physician.

Despite understanding the diet, only 52% of patients adhered to it regularly, indicating a need for dietitian support to improve compliance and management of IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a low FODMAPs diet without initial dietician intervention in the management of patients with irritable bowel syndrome: a prospective study. Van Ouytsel, P., Szalai, A., Van Gossum, A., et al.[2022]

In a study involving adults with irritable bowel syndrome (IBS), the low FODMAP diet (LFD) showed a clinical response rate of 50% in the LFD group and 67% in the LFD supplemented with B-galactooligosaccharide (LFD/B-GOS) group, compared to 30% in the control group, indicating that the LFD can be effective for managing IBS symptoms.

Baseline levels of certain faecal metabolites, such as propionate and cyclohexanecarboxylic acid esters, were found to predict clinical response to the LFD, suggesting that these metabolites could help identify which patients are more likely to benefit from the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faecal and urine metabolites, but not gut microbiota, may predict response to low FODMAP diet in irritable bowel syndrome. Wilson, B., Kanno, T., Slater, R., et al.[2023]

Low-carbohydrate, high-fat (LCHF) nutrition therapy can significantly improve health outcomes in critically ill patients by reducing hyperglycemia, enhancing respiratory function, and potentially decreasing hospital stays and costs.

LCHF therapy may be particularly beneficial in the ICU setting as it helps conserve protein and glucose for essential metabolic functions, making it a promising area for further research, especially in the context of COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of low-carbohydrate diets in the intensive care unit. Hajjar, J., Dziegielewski, C., Dickson, S., et al.[2023]

In a study of 30 children aged 7 to 12 with functional gastrointestinal disorders, higher baseline quality of life was linked to better adherence to the low-FODMAP diet over a 3-week period.

Baseline emotional and behavioral problems, as well as abdominal pain, did not significantly predict adherence to the diet, suggesting that a child's overall well-being may be more important for following dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Adherence to a Low Fermentable Carbohydrate Diet in Children With Functional Gastrointestinal Disorders. Tenenbaum, RB., Czyzewski, D., McMeans, A., et al.[2023]

In a study of 205 IBS patients followed for an average of 44 months, 60% reported adequate symptom relief while adhering to a personalized low FODMAP diet (pLFD).

Most participants (80%) continued to consume 'free-from' products, particularly gluten or wheat-free items, indicating a long-term commitment to dietary changes for managing their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The low FODMAP diet for IBS; A multicentre UK study assessing long term follow up. Rej, A., Shaw, CC., Buckle, RL., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8500369/

Effect of low carbohydrate diets on insulin resistance and the ...

... diet, where carbohydrate intolerant patients consume high levels of refined carbohydrate. ... Outcomes of a digitally delivered low-carbohydrate type 2 diabetes ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1871402124001103

Association of low carbohydrate diet score with the risk ...

A low carbohydrate diet reduces the delivery of sugars to the liver suppressing insulin levels and resulting in improved insulin sensitivity (pre-prandial) and ...

3.

diabetesjournals.org

diabetesjournals.org/spectrum/article/33/2/133/32999/Low-Carbohydrate-and-Very-Low-Carbohydrate-Diets

Low-Carbohydrate and Very-Low-Carbohydrate Diets in ...

Insulin sensitivity improved by 75% when measured via euglycemic-hyperinsulinemic clamp; mean A1C improved from 7.3 to 6.8% in 14 days. This ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10937533/

Expert consensus on nutrition and lower-carbohydrate diets

With evidence indicating that lower-carbohydrate dietary patterns are associated with beneficial effects on weight maintenance, insulin sensitivity, and markers ...

5.

bmj.com

bmj.com/content/372/bmj.m4743

Efficacy and safety of low and very low carbohydrate diets ...

Large clinically important improvements were seen in weight loss, triglycerides, and insulin sensitivity at six months, which diminished at 12 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7390653/

Low-carbohydrate diets and cardiometabolic health

... with a lower dose of acarbose in Chinese adults with impaired glucose tolerance and pre-existing coronary heart disease. High dietary fiber. Systematic ...

7.

publications.aap.org

publications.aap.org/pediatrics/article/152/4/e2023063755/193955/Low-Carbohydrate-Diets-in-Children-and-Adolescents

Low-Carbohydrate Diets in Children and Adolescents With ...

In addition to dietary change, regular physical activity decreases insulin resistance, improves glucose tolerance, and is a major component of ...