Low Glycemic Load Diet for Cystic Fibrosis and Diabetes
(DINE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rhode Island Hospital
Must be taking: Insulin
Must not be taking: Glucocorticoids
Disqualifiers: Low BMI, Pregnancy, CF exacerbation, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12678How 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.
12348Eligibility 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.
I am 18 years old or older.
My cystic fibrosis diagnosis was confirmed through genetic testing.
+1 more
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.
+4 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Low Glycemic Load DietExperimental Treatment1 Intervention
Feeding study with dietary composition (approximately) 50% fat, 20% protein, 30% carbohydrate.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rhode Island HospitalProvidence, RI
Boston Children's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Rhode Island HospitalLead Sponsor
Cystic Fibrosis FoundationCollaborator
References
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]Low glycemic index diets seem to be potentially effective to improve glycemic control and reduce lipid profiles. Hence, this study aimed to evaluate the effect of a low glycemic index/high fat, high-calorie diet on glycemic status and lipid profiles of patients with cystic fibrosis.
Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. [2022]Glycemic index and glycemic load are used to facilitate glucose control among adults with type 2 diabetes, with a low glycemic index diet associated with improved glycemic control.
Dietary glycemic index and glycemic load are associated with metabolic control in type 2 diabetes: The CAPRI experience. [2022]The role of low-glycemic-index diets in the treatment of diabetes mellitus remains unclear. The aim of the present study was to evaluate the association between the dietary glycemic index (GI) and glycemic load (GL) with metabolic control in type 2 diabetic patients.
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]The optimal diet to improve glycemia in patients with type 2 diabetes remains unclear. Low carbohydrate, high fat (LCHF) diets can improve glycemic control, but have not been investigated in real-world settings.
Influence of the glycemic index and glycemic load of the diet in the glycemic control of diabetic children and teenagers. [2015]Evaluate the influence of the glycemic index (GI) and glycemic load (GL) of the diet in the glycemic control of children and teenagers with type 1 diabetes mellitus (DM1).
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](1) Background: This systematic review and meta-analysis aims to evaluate the impact of a low glycemic index (LGI) and low glycemic load (LGL) diet on children with overweight and obesity, analyzing any changes in anthropometric, cardiometabolic, and glucometabolic parameters. (2) Methods: Three electronic databases (PubMed, Scopus, CENTRAL), as well as clinical trial registries and reference lists of the included studies, were searched for eligible randomized control trials (RCTs). Two independent reviewers performed the screening of the studies, data extraction, and risk of bias assessment. Mean difference (MD) and 95% confidence intervals (CI) using a random effects model were calculated for each outcome. (3) Results: Eleven RCTs (n = 634) examining the effect of LGI diet versus control were identified. The synthesized data provided from the RCTs indicate no difference between intervention and control groups regarding primary outcomes (body weight (MD: -0.14; 95% CI -1.93 to 1.64, 5 trials), body mass index (BMI) (MD: -0.31; 95% CI -0.85 to 0.23, 6 trials), BMI z-score (MD: -0.03; 95% CI -0.09 to 0.02, 5 trials), and waist circumference (MD: -0.52; 95% CI -2.35 to 1.31, 5 trials)) and other measures of cardiometabolic and glucometabolic parameters. The majority of trials were classified as "some concerns". (4) Conclusions: LGI and LGL diets do not seem to be associated with changes in adiposity, cardiometabolic or glucometabolic markers in children with overweight or obesity. Further research comparing the LGI diet to a high glycemic index diet, with proper methodological standards, is required to clarify the benefits of a LGI diet in this population.
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]The aim of the present meta-analysis was to investigate the long-term effects of glycemic index-related diets in the management of obesity with a special emphasis on the potential benefits of low glycemic index/load (GI/GL) in the prevention of obesity-associated risks.
More favorable dietary patterns are associated with lower glycemic load in older adults. [2016]Glycemic load represents the total glycemic effect of the diet and may reduce the risk for chronic disease by affecting the risk for obesity and by altering metabolic endpoints. The food choices associated with lower-glycemic-load diets have received little investigation. Therefore, the purpose of this research was to examine the food patterns associated with lower-glycemic-load diets to establish targeted intervention messages.