Low Glycemic Load Diet for Cystic Fibrosis and Diabetes

(DINE Trial)

Recruiting at 1 trial location

Overseen By Melissa S Putman, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must be taking: Insulin

Must not be taking: Glucocorticoids

Disqualifiers: Low BMI, Pregnancy, CF exacerbation, others

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

Compensation: Varies

Number of Visits: 6

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a low glycemic load diet, which focuses on foods that don't spike blood sugar, can benefit people with cystic fibrosis-related diabetes. Researchers aim to determine if this diet can improve blood sugar levels, reduce insulin needs, and enhance overall quality of life for participants. They also examine how this diet affects body composition and digestive symptoms using continuous glucose monitors. This trial suits adults diagnosed with cystic fibrosis who rely on pancreatic enzyme replacements and manage diabetes with insulin or have high blood sugar levels. As an unphased trial, it offers participants the chance to contribute to pioneering research that could improve diabetes management for those with cystic fibrosis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using IV antibiotics or certain steroids for CF exacerbation, you must not have used them within the last month before joining the trial.

What prior data suggests that this dietary intervention is safe for individuals with cystic fibrosis-related diabetes?

Research has shown that a low glycemic load (LGL) diet is safe and easy to follow for adults with cystic fibrosis (CF). In past studies, adults with CF who tried an LGL diet experienced no major safety problems. The diet was easy to manage and did not cause serious side effects. This evidence suggests that an LGL diet is a safe choice for people with CF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cystic fibrosis and diabetes, which often rely on medications like insulin or enzyme supplements, the Low Glycemic Load Diet is a nutritional approach that focuses on diet composition. This diet is unique because it emphasizes a balance of approximately 50% fat, 20% protein, and 30% carbohydrate, aiming to stabilize blood sugar levels and reduce insulin spikes. Researchers are excited about this treatment because it offers a non-pharmaceutical option that could potentially improve metabolic control and overall health in individuals with cystic fibrosis and diabetes by managing blood sugar levels through diet alone.

What evidence suggests that a low glycemic load diet might be an effective treatment for cystic fibrosis-related diabetes?

Research shows that a low glycemic load (LGL) diet is safe and well tolerated by adults with cystic fibrosis (CF) who have abnormal blood sugar levels. This diet involves consuming foods that release sugar slowly into the bloodstream, helping to manage blood sugar levels. Although few studies specifically address its effectiveness for cystic fibrosis-related diabetes (CFRD), this diet has been linked to better blood sugar control in other conditions. Some evidence suggests that LGL diets may not differ significantly from other diets in overall results, yet they remain promising for managing blood sugar. Overall, this diet might help control abnormal blood sugar levels in people with CF. Participants in this trial will follow the LGL diet to evaluate its impact on blood sugar management in CF. ^{1 2 3 5 6}

Who Is on the Research Team?

Melissa S Putman, MD, MSc

Principal Investigator

Boston Children's Hospital

Kevin J Scully, MB BCh BAO

Principal Investigator

Rhode Island Hospital

Are You a Good Fit for This Trial?

Adults with cystic fibrosis-related diabetes (CFRD) who are over 18, have had certain levels of blood glucose or HbA1c in the past two years, use insulin, and require pancreatic enzyme replacement can join. Those pregnant, on specific diets, with severe lung function impairment or recent changes in CF treatments cannot participate.

Inclusion Criteria

I need medication to help my pancreas work.

My cystic fibrosis diagnosis was confirmed through genetic testing.

I have diabetes as shown by my glucose test, HbA1c levels, or I'm using insulin.

Exclusion Criteria

Your lung function test shows that you have less than 50% of the expected breathing capacity.

I have started or stopped a CFTR modulator treatment within the last 3 months.

I haven't used IV antibiotics or high-dose steroids for cystic fibrosis flare-ups in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants follow their standard diet for a 10-day run-in period

1.5 weeks

1 visit (in-person)

Meal Delivery

Participants transition to a low glycemic load diet provided by a meal delivery company

8 weeks

2 visits (in-person)

Free-living

Participants adhere to a low glycemic load diet under free-living conditions with close nutritionist follow-up

16 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low Glycemic Load Diet

Trial Overview The trial is testing how a low glycemic load diet affects blood sugar control and body composition in adults with CFRD. Participants will be monitored using continuous glucose monitors both during controlled meal delivery and free-living conditions to evaluate the diet's effectiveness.

How Is the Trial Designed?

Group I: Low Glycemic Load Diet Experimental Treatment 1 Intervention

Feeding study with dietary composition (approximately) 50% fat, 20% protein, 30% carbohydrate.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Published Research Related to This Trial

A systematic review of 11 randomized control trials involving 634 children found that low glycemic index (LGI) and low glycemic load (LGL) diets did not lead to significant changes in body weight, BMI, or waist circumference compared to control diets.

The study suggests that LGI and LGL diets do not improve cardiometabolic or glucometabolic health markers in children with overweight or obesity, indicating a need for further research to explore their potential benefits against high glycemic index diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Low Glycemic Index/Load Diet on Cardiometabolic, Glucometabolic, and Anthropometric Indices in Children with Overweight or Obesity: A Systematic Review and Meta-Analysis. Kalaitzopoulou, I., Theodoridis, X., Kotzakioulafi, E., et al.[2023]

In a study of 901 type 2 diabetic patients, those who followed diets with lower glycemic index (GI) and glycemic load (GL) had significantly lower levels of HbA1c, indicating better long-term blood sugar control.

Patients with the highest GI and GL had an average HbA1c increase of 1% compared to those with the lowest, highlighting the importance of dietary choices in managing diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary glycemic index and glycemic load are associated with metabolic control in type 2 diabetes: The CAPRI experience. Esposito, K., Maiorino, MI., Di Palo, C., et al.[2022]

In a study involving 44 children and adolescents with cystic fibrosis, a low glycemic index/high fat, high-calorie diet significantly improved fasting blood glucose and glycated hemoglobin levels compared to a standard high fat, high-calorie diet over three months.

The low glycemic index diet led to a decrease in fasting blood glucose and glycated hemoglobin, while the standard diet resulted in an increase in fasting blood glucose and triglycerides, highlighting the potential benefits of dietary management in glycemic control for cystic fibrosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low glycemic index/high-fat, high-calorie diet on glycemic control and lipid profiles of children and adolescence with cystic fibrosis: A randomized double-blind controlled clinical trial. Gorji, Z., Modaresi, M., Yekanni-Nejad, S., et al.[2020]

In a study of 146 children and teenagers with type 1 diabetes, those with good glycemic control had significantly lower glycemic index (GI) and glycemic load (GL) in their diets compared to those with intermediate and poor control.

A diet with medium GL and lower GI, which also included higher protein content, was associated with better glycemic control, suggesting that dietary choices can positively influence blood sugar management in young patients with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of the glycemic index and glycemic load of the diet in the glycemic control of diabetic children and teenagers. Queiroz, KC., Novato Silva, I., de Cássia Gonçalves Alfenas, R.[2015]

In a study of 238 low-income Latino adults with type 2 diabetes, increases in glycemic index over 12 months were linked to higher HbA1c levels and increased waist circumference, indicating a negative impact on glycemic control.

Lowering the glycemic index may improve metabolic risk factors, suggesting that dietary strategies focusing on glycemic index could be beneficial for diabetes self-management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. Wang, ML., Gellar, L., Nathanson, BH., et al.[2022]

A study of 179 older adults found that those following a lower-glycemic-load diet had significantly lower glycemic loads compared to those on a higher-glycemic-load diet, suggesting dietary patterns can influence metabolic health.

Participants in the lower-glycemic-load group consumed more nutrient-dense carbohydrates like whole grains, fruits, and vegetables, indicating that promoting these foods could help reduce the risk of obesity and chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More favorable dietary patterns are associated with lower glycemic load in older adults. Davis, MS., Miller, CK., Mitchell, DC.[2016]

In a study of 49 patients with type 2 diabetes following a low carbohydrate, high fat (LCHF) diet for at least 3 months, there was a significant reduction in A1C levels by -1.29% compared to 75 matched controls receiving usual care, indicating improved glycemic control.

The LCHF diet also led to greater weight loss (average -12.8 kg) and allowed 100% of insulin users in the LCHF group to either discontinue or reduce their insulin dosage, suggesting it may be a beneficial dietary approach for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the low carbohydrate, high fat diet on glycemic control and body weight in patients with type 2 diabetes: experience from a community-based cohort. Ahmed, SR., Bellamkonda, S., Zilbermint, M., et al.[2021]

A meta-analysis of 14 randomized controlled trials found that long-term low glycemic index/load (GI/GL) diets significantly reduced fasting insulin levels and C-reactive protein, which are important markers for obesity-related health risks.

While low GI/GL diets showed benefits in reducing certain biomarkers, they also resulted in a significant decrease in fat-free mass, indicating a need for careful monitoring of body composition during such dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of low glycemic index/load vs. high glycemic index/load diets on parameters of obesity and obesity-associated risks: a systematic review and meta-analysis. Schwingshackl, L., Hoffmann, G.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11462092/

Safety and tolerability of a low glycemic load dietary ... The objective of this pilot study was to investigate the safety and tolerability of a low glycemic load (LGL) diet in adults with CF and abnormal glucose ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04519853

A Pilot Study of a Low Glycemic Load Diet in Adults With ... This pilot study will evaluate the safety and tolerability of a low glycemic load dietary intervention in adult patients with cystic fibrosis (CF) in a ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39385793/

Safety and tolerability of a low glycemic load dietary ... A LGL dietary intervention was safe and well tolerated in adults with CF and AGT. These results lay the groundwork for future trials ...

4. clinicaltrial.be clinicaltrial.be/en/details/191514?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=1&per_page=100

The Effects of a Low Glycemic Load Diet on Dysglycemia ... There are currently no prospective studies evaluating the impact of diet quality on glycemic control and body composition in patients with CF.

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD005105.pub3/full

Low glycaemic index or low glycaemic load diets for ... The current evidence indicates there may be little to no difference for all main outcomes between low GI/GL diets versus higher GI/GL diets or ...

6. childrenshospital.org childrenshospital.org/clinical-trials/nct05723445

The Effects of a Low Glycemic Load Diet on Dysglycemia ... The investigators hypothesize that an LGL diet will result in improved CGM-derived measures of hyperglycemia, a decrease in insulin requirements, and reductions ...