A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D)

NCT06640478 | Active Not Recruiting DMC

• 1 other identifier: STUDY00020631
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes (T1D). Feasibility, acceptability, and fidelity of this intervention will be measured. We will also explore the likelihood of prolonging the honeymoon phase of T1D in the intervention study group. Comparisons will be made between this combined nutrition intervention and free healthy foods vs. current standard nutrition counseling. Both study groups will receive standard of care treatment for T1D (insulin therapy). The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 of T1D, and may lead to prolongation of the honeymoon phase. The overall goal is to promote the beta cell function survival and to reduce the progression to stage 4 of T1D. Condition or Disease:

• Type 1 Diabetes Mellitus
• New Diagnosis of Stage 3 Type 1 Diabetes ≤ 60days Intervention/Treatment: \- Weekly Free Healthy Foods + Intensive Nutrition Counseling for 12 weeks

Conditions

Type 1 Diabetes

Keywords

T1D; Healthy foods; Children; Youth; Nutrition Counseling; Diabetes mellitus type 1; Nutrition; Honeymoon phase; partial remission of diabetes; new diagnosis of type 1 diabetes; healthy eating; Nutrition Intervention

Outcome Measures

Primary Outcomes (9)

• Recruitment rates

  Number of subjects screened over the course of the study

  6 months

• Enrollment rates

  Number of subjects participating over the course of the study

  6 months

• Amount of time required to recruit the target sample (approx. 12- 20 people)

  Number of months necessary to meet recruitment goals

  6 months

• Number of subjects required to be screened to meet required sample size (approx. 12- 20 people)

  Number of subjects screened to meet enrollment goals

  6 months

• Number of participants who completed the 12-week intervention

  Number of subjects completing the intervention

  12 weeks

• Average number of provided foods consumed during the day over the course of the intervention

  Average number of provided foods consumed during the day over the course of the intervention

  12 weeks

• Number of participants who completed the Mixed-meal tolerance test at the enrollment visit

  Number of subjects completing the MMTT at baseline

  Baseline

• Number of participants who completed the Mixed-meal tolerance test at the 12-week visit

  Number of subjects completing the MMTT at 12 week visit

  12 weeks

• Number of participants who completed the Mixed-meal tolerance test at the 24-week visit

  Number of subjects completing the MMTT at 24 week visit

  24 weeks

Secondary Outcomes (46)

• Healthy Eating Index (HEI) change from baseline to the 12-week visit

  12 weeks

• Healthy Eating Index (HEI) change from baseline to the 24-week visit.

  24 weeks

• Weight changes from baseline visit to the 12-week visit

  12weeks

• Weight changes from baseline visit to the 24-week visit

  24 weeks

• Weight Z-score changes from baseline visit to the 12 week visit

  12 weeks

Other Outcomes (5)

• Area under the curve and peak C-peptide level determined by MMTT (Mixed Meal Tolerance Test)

  2 hours

• Change in the total daily dose of exogenous insulin (TDD) as units/kg/day from baseline to the 12-week visit

  12 weeks

• Change in the total daily dose of exogenous insulin (TDD) as units/kg/day from baseline to the 24-week visit.

  24 weeks

Study Arms (2)

NUTRI-Beta Intervention Group

ACTIVE COMPARATOR

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

Other: NUTRI-Beta Counseling; Dietary Supplement: Free weekly produce foods

Standard of care nutrition counseling (MyHealthy plate model and ADA clinical guidelines)

OTHER

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

Dietary Supplement: Standard dietary counseling

Interventions

Free weekly produce foods DIETARY_SUPPLEMENT

Free weekly produce

NUTRI-Beta Intervention Group

NUTRI-Beta Counseling OTHER

Dietary Counseling focused on anti-inflammatory foods

Also known as: NUTRI-Beta Intervention

NUTRI-Beta Intervention Group

Standard dietary counseling DIETARY_SUPPLEMENT

Standard of Care therapy: Nutrition counseling per the ADA clinical guidelines and USDA MyPlate model

Also known as: Standard

Standard of care nutrition counseling (MyHealthy plate model and ADA clinical guidelines)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Willing and able to give assent and to have a parent or legal guardian to provide informed consent
• Less or equal than 60 days from T1D diagnosis based on American Diabetes Association criteria, and metabolically stable per study physician assessment
• Boys and girls (Any Tanner stage), 6-17 years of age, at time of enrollment visit
• Evidence of at least one positive T1D autoantibody (excluding insulin antibodies in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit
• Children with new diagnosis of T1D need to be established patients from Penn State Health- Pediatric diabetes clinic at the time of the enrollment visit
• Capability to eat different types of food by mouth
• Daily use of a 24-hour continuous glucose monitor by the time of the enrollment visit
• Willing and being able to give assent and have a parent or legal guardian provide informed consent

You may not qualify if:

• Children with new diagnosis of T1D who are not metabolically stable (E.g. acute dehydration, severe hyperglycemia with moderate/large ketones at the time of the enrollment visit)
• Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies to control hyperglycemia including immunosuppressive therapies
• Chronic inflammatory or autoimmune diseases with exception of stable autoimmune thyroid disease
• Children requiring enteral feeds or parenteral nutrition support
• Diagnosis of celiac disease or being actively evaluated for possible celiac disease, inflammatory bowel disease or any underlying illness cause acute or chronic intestinal malabsorption.
• Use of glucocorticoids or other immunosuppressive agents within 30 days of T1D diagnosis
• Use of medications known to influence glucose intolerance within 30 days of T1D diagnosis
• Food allergies (nuts, soy, seafood, milk-protein, or as deemed by the principal investigator) that are a barrier for consumption of a balanced diet that meets nutrient requirements
• Prior diagnosis or positive screening of food sensory disorders
• Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation to the study results

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (2)

Penn State Health Children's

Hershey, Pennsylvania, 17033, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lina Huerta Saenz, MD, FAAP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Sub-investigators, research assistants
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Pediatrics

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (2)