Nutrition and Counseling for Type 1 Diabetes

(NUTRI-Beta Trial)

Recruiting at 1 trial location

Overseen By Lina Huerta Saenz, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Must be taking: Insulin

Must not be taking: Glucocorticoids, Immunosuppressants

Disqualifiers: Celiac, Inflammatory bowel, Food allergies, others

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

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether providing free healthy foods and intensive nutrition counseling can help manage type 1 diabetes in children recently diagnosed. The goal is to determine if this approach can support insulin therapy and possibly extend the "honeymoon phase," during which the body still produces some insulin. Participants will either receive the new nutrition plan with insulin or continue standard nutrition guidance with insulin. Children diagnosed with type 1 diabetes in the last 60 days who can eat a variety of foods might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management strategies for children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used non-insulin therapies or certain medications affecting glucose levels within 30 days before the trial.

What prior data suggests that this nutrition and counseling intervention is safe for children with type 1 diabetes?

Research has shown that nutrition plays a crucial role in managing type 1 diabetes. Intensive nutrition counseling and healthy food choices can lead to better health outcomes. Previous studies have found these programs to be generally safe for children with type 1 diabetes, aiming to improve diet quality and effectively manage blood sugar levels.

This trial focuses on providing children with weekly bags of healthy food and intensive nutrition counseling. These foods adhere to current dietary guidelines and include fruits, vegetables, nuts, and seafood, which are known to support overall health and are usually well-tolerated.

There is no direct evidence of negative effects from this type of nutritional intervention. However, monitoring any dietary changes remains important, especially in children with medical conditions. This approach does not involve new medication or invasive procedures, which typically raise more safety concerns. Instead, it enhances standard insulin therapy by emphasizing nutrition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Counseling for Type 1 Diabetes approach because it combines intensive nutrition counseling with the direct provision of healthy foods, potentially enhancing blood sugar control. Unlike standard care, which typically involves general dietary advice and insulin therapy, this approach provides a curated weekly food bag filled with vitamin-rich fruits, vegetables, nuts, legumes, yogurt, and seafood, aligning with USDA dietary guidelines. This method not only ensures patients receive optimal nutrition but also offers constant monitoring through continuous glucose monitoring, potentially leading to more stable blood sugar levels and improved overall diabetes management.

What evidence suggests that this nutrition and counseling intervention could be effective for type 1 diabetes?

This trial will compare two approaches to nutrition and counseling for people with type 1 diabetes (T1D). Participants in the NUTRI-Beta Intervention Group will receive weekly free healthy foods and intensive nutrition counseling, which research has shown can improve T1D management. Studies have found that low-carbohydrate diets lead to better blood sugar control in T1D. Specifically, one study discovered that meals tailored for medical needs improved both diet and food security for diabetes patients. Good nutrition plays a crucial role in managing T1D and may extend the "honeymoon phase," a period when the condition is easier to manage. Overall, this approach could benefit people with T1D by promoting healthy eating habits. ^{3 5 6 7 8}

Who Is on the Research Team?

Lina Huerta Saenz, MD, FAAP

Principal Investigator

Pediatric Endocrinologist, Assistant Professor of Pediatrics, Penn State Health Milton Hershey Medical Center, Penn State College of Medicine

Are You a Good Fit for This Trial?

This trial is for children recently diagnosed with stage 3 Type 1 Diabetes (within the last 45 days). It's designed to see if a combination of free healthy foods and intensive nutrition counseling, along with standard insulin therapy, can help manage their condition better than just standard advice.

Inclusion Criteria

Willing and able to give assent and to have a parent or legal guardian to provide informed consent

I have tested positive for at least one type 1 diabetes autoantibody.

Willing and able to give assent and have a parent or legal guardian provide informed consent

Exclusion Criteria

Prior diagnosis or positive screening of food sensory disorders

I haven't taken any diabetes-affecting meds in the last 30 days.

I have used non-insulin treatments for high blood sugar in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline visit including enrollment and initial assessments

1 day

1 visit (in-person)

Treatment

Participants receive weekly distribution of healthy foods and intensive nutrition counseling for 12 weeks

12 weeks

7 visits (4 in-person, 3 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Weekly Free Healthy Foods + Intensive Nutrition Counseling

Trial Overview The study tests whether providing weekly healthy foods and detailed nutrition guidance improves the management of Type 1 Diabetes in children. The goal is to extend the 'honeymoon phase', where diabetes is easier to control, compared to usual care.

How Is the Trial Designed?

Group I: Standard of care nutrition counseling (MyHealthy plate model and ADA clinical guidelines) Experimental Treatment 1 Intervention

STANDARD OF CARE NUTRITION COUNSELING: 1. A 12-week distribution of weekly grocery store gift cards of similar monetary value of the NUTRI-Beta food bag in addition to 2. MyPlate USDA model with similar frequency of nutrition counseling visits but following the American Dietary Association (ADA) Guidelines, and 3. Standard insulin treatment (either insulin injections or insulin pump per patient preference) and 24-hour continuous glucose monitor

Group II: NUTRI-Beta Intervention Group Active Control 2 Interventions

We will provide healthy foods (NUTRI-Beta Food bag) to the intervention group weekly for 12 weeks, in addition to an intensive nutrition counseling program (NUTRI-Beta Counseling) and close 24-hour continuous glucose monitoring. The healthy foods bag will contain a combination of 6 types of foods including: 1. seasonal fruits (containing high amounts of vitamin C and E) 2. legumes, 3. nuts, 4. yogurt, and 5. seasonal vegetables (carotenoids, tomatoes, broccoli, celery, etc.). 6. seafood or seafood-related products The portions of each food group component of the NUTRI-Beta basket will follow the current USDA dietary guidelines according to the age of the participant: a) Intervention group will receive NUTRI-Beta foods bag + intensive nutrition counseling (NUTRI-Beta dietary counseling) + standard insulin treatment (either insulin injections or insulin pump per patient preference) and T1D technology use

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

Published Research Related to This Trial

This scoping review analyzed 22 articles and eight systematic reviews on nutrition management for children and adolescents with type 1 diabetes, revealing a focus on carbohydrate counting and dietary intake patterns rather than personalized dietary counseling.

Only four studies included tailored nutrition interventions, highlighting a significant gap in research regarding the effectiveness of individualized medical nutrition therapy for long-term management in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Interventions in Pediatric Patients with Type 1 Diabetes: An Evidence Analysis Center Scoping Review. Handu, D., Piotrowski, M.[2022]

Individuals with type 1 diabetes require personalized nutrition therapies to enhance their health and metabolic outcomes, but many are not following recommended dietary guidelines.

Various meal planning strategies, such as basic nutrition guidelines and carbohydrate counting, have been proposed to help patients better manage their diets, although the effectiveness of these interventions remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary strategies for adult type 1 diabetes in light of outcome evidence. Matteucci, E., Giampietro, O.[2021]

Nutritional management is crucial for effectively treating both insulin-dependent (IDDM) and noninsulin-dependent diabetes mellitus (NIDDM), with different goals tailored to each type due to their distinct underlying causes.

The article provides practical tools, including meal plans and lists of high-fiber, low-fat foods, to help healthcare providers support patients in managing their diabetes through diet, especially when nutrition consultations are not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes and nutrition recommendations: a practical perspective. Franz, MJ., Reader, D.[2008]

A well-structured meal plan is essential for patients with insulin-dependent diabetes mellitus (IDDM) to manage blood sugar levels and maintain metabolic balance, taking into account factors like age, sex, and physical activity.

The American Diabetes Association recommends that 50-65% of total calories come from carbohydrates, with specific guidelines for protein and fat intake, emphasizing the importance of individualized meal planning based on self-monitoring of blood glucose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric, adolescent, and young-adult nutrition issues in IDDM. Brink, SJ.[2019]

A study involving 43 nonketosis-prone diabetic patients showed that a simplified 1-hour nutritional counseling program significantly improved their nutritional knowledge.

Following the counseling, patients with previously inadequate diabetes control also demonstrated significant improvements in their diabetes management, highlighting the effectiveness of targeted nutritional education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nutritional counseling on the blood glucose and nutritional knowledge of diabetic subjects. Chandalia, HB., Bagrodia, J.[2019]

A 1-week nutritional education program for 83 diabetic patients led to significant long-term changes in dietary habits, with type 1 patients reducing caloric, protein, and fat intake, while type 2 patients showed varied results in carbohydrate and fat consumption.

Two years post-education, 45% of the patients adhered to the European Association Study for Diabetes (EASD) nutritional recommendations, indicating the program's effectiveness in promoting healthier eating behaviors among diabetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a psycho-educational nutritional program in diabetic patients. Schalch, A., Ybarra, J., Adler, D., et al.[2022]

A simple educational program significantly improved dietary knowledge and carbohydrate (CHO) counting skills in 48 Type 1 diabetes patients over four interactive meetings, leading to better management of their condition.

The improvements in dietary knowledge and CHO management persisted for at least 7 months after the course, indicating that such educational interventions can establish lasting habits for better diabetes control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching and training programme on carbohydrate counting in Type 1 diabetic patients. Bruttomesso, D., Pianta, A., Crazzolara, D., et al.[2019]

A flexible diet education and meal planning system for diabetic patients is most effective when led by a diet counselor, such as a registered dietitian or nurse educator.

Physicians play a crucial role in supporting this program by discussing patient progress with the diet counselor and reinforcing the dietary efforts, ensuring a collaborative approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized diets for diabetic patients. Nuttall, FQ., Maryniuk, MD., Kaufman, M.[2019]

Patients with type 1 diabetes (T1D) generally have lower energy intake compared to the general population, but their protein intake aligns with dietary recommendations, indicating some adherence to nutritional guidelines.

Despite some compliance, T1D patients often consume insufficient dietary fiber and carbohydrates, suggesting a need for better education on diabetes dietary management to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Intake and Adherence to the Recommendations for Healthy Eating in Patients With Type 1 Diabetes: A Narrative Review. Pancheva, R., Zhelyazkova, D., Ahmed, F., et al.[2022]

An 18-month family-based behavioral intervention significantly improved dietary quality in children with type 1 diabetes, as shown by increased scores in the Healthy Eating Index (HEI2005) and Whole Plant Food Density (WPFD).

Despite the positive changes in diet, the intervention did not lead to improvements in glycemic control, indicating that while dietary quality can be enhanced, it may not directly affect blood sugar levels in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving dietary quality in youth with type 1 diabetes: randomized clinical trial of a family-based behavioral intervention. Nansel, TR., Laffel, LM., Haynie, DL., et al.[2022]

Effective nutrition education for adults involves a structured three-phase approach: assessment, intervention, and evaluation, which is crucial for addressing various health issues like weight reduction and diabetes.

Maintaining behavioral changes post-education is a significant challenge, highlighting the need for well-trained nutrition education providers and effective strategies to support long-term adherence to dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education for risk factor reduction and patient education: a review. Glanz, K.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06640478

A 12-week Pilot Nutrition Intervention for Children With ... The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6566372/

Carbohydrate Restriction in Type 1 Diabetes: A Realistic ... Low carbohydrate diets (LCD; <130 g/day) may represent a means to improve glycaemic control and metabolic health in people with T1D.

3. mdpi.com mdpi.com/2072-6643/16/21/3639

Insights in Nutrition to Optimize Type 1 Diabetes Therapy Nutrition is an essential part of therapy for type 1 diabetes and is constantly evolving, offering growing opportunities to prevent this disease.

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2812982

Effect of an Intensive Food-as-Medicine Program on Health ... A randomized crossover study found that delivering medically tailored meals to patients with diabetes improved diet and food security, and a ...

5. diabetesjournals.org diabetesjournals.org/books/book/chapter-pdf/759310/bk9781580406482-01.pdf

Effectiveness of Nutrition Therapy and Healthy Eating ... In persons with type 1 diabetes, weight outcomes were also mixed. In studies reporting BMI, nine study arms reported significant decreases from 0.3–2.1 kg ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06640478

A 12-week Pilot Nutrition Intervention for Children With ... The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11642502/

Nutritional Guidelines for Patients with Type 1 Diabetes ... The safe amounts of carbohydrates, protein and fat includes 50–55%, 15–20% and 25–30% of total energy respectively with fiber intake recommended ...

8. publications.aap.org publications.aap.org/monograph/chapter-pdf/1764294/ch28.pdf

Nutrition Therapy for Children and Adolescents With Type ... Strategies that promote a healthy weight by improving diet quality, minimizing beverages with added sugar and limiting juice intake to moderate ...