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

Trial Summary

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 data supports the effectiveness of the Low Glycemic Load Diet treatment for Cystic Fibrosis and Diabetes?

Research shows that low glycemic index diets can help improve blood sugar control in people with diabetes, and similar diets have been found to potentially improve blood sugar and cholesterol levels in children with cystic fibrosis. ^{1 2 3 4 5}

Is a low glycemic load diet safe for humans?

Research on low glycemic load diets, including studies on children with cystic fibrosis and those with obesity, suggests that these diets are generally safe for humans. They have been associated with improved blood sugar control and do not show significant adverse effects in the studies reviewed. ^{1 2 6 7 8}

How is the Low Glycemic Load Diet treatment different from other treatments for cystic fibrosis and diabetes?

The Low Glycemic Load Diet is unique because it focuses on controlling blood sugar levels by choosing foods that have a low impact on blood sugar, which can help improve glycemic control and reduce lipid levels in patients with cystic fibrosis and diabetes. This approach is different from other treatments that may not specifically target the glycemic index of foods. ^{1 2 3 4 8}

What is the purpose of this trial?

This study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related diabetes (CFRD). We will use continuous glucose monitors (CGM) to assess the LGL diet both in a controlled setting (via a meal delivery company) and in free-living conditions.

Research Team

Kevin J Scully, MB BCh BAO

Principal Investigator

Rhode Island Hospital

Melissa S Putman, MD, MSc

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

References

1. Netherlands 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dietary glycemic index and glycemic load are associated with metabolic control in type 2 diabetes: The CAPRI experience. [2022]

4. England 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. [2021]

5. Spain 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. [2015]

6. Switzerland 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. [2023]

7. Netherlands 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

More favorable dietary patterns are associated with lower glycemic load in older adults. [2016]