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

NUTRI-Beta Study: A Pilot Clinical Trial for Children With New Diagnosis of Stage 3 Type 1 Diabetes

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

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: NUTRI-Beta Counseling; Dietary supplement: Free weekly produce foods; Dietary supplement: Standard dietary counseling

Detailed Description

The proposed study is a 12-week pilot, single-blinded, randomized, controlled clinical trial in prepubertal children (6-17 years old) newly diagnosed with stage 3 of type 1 diabetes (T1D) within 60 days. The total duration of the study is 24 weeks, but the nutrition intervention is only delivered during 12 weeks with a 24-week follow up visit. We expect to enroll a total of 12-40 children (6-20 per study group).

We will be investigating the potential role of a frequent personalized nutrition counseling intervention (7 sessions in a hybrid model) in addition to weekly distribution of selected healthy foods. We expect the diet quality of the youth receiving the intervention (you) will improve during and after the study intervention.

There will be two study groups: intervention and control group.

The intervention group will receive a food bag containing specific healthy foods with high anti-inflammatory properties weekly for 12 weeks, in addition to seven nutrition counseling sessions. The provided foods are a combination of 6 types of foods including: a) seasonal fruits (containing high amounts of vitamin C and vitamin E), b) legumes, c) nuts, d) yogurt, e) vegetables and f) seafood. The portions of each food group component of the "healthy foods bag" will follow the current USDA dietary guidelines according to the age of the study participant. [1] By contrast, the control group will receive weekly grocery store gift cards of similar monetary value of the "healthy food bag" in addition to seven nutrition counseling sessions based on the standard MyHealthy plate model.

In regards to the nutrition counseling sessions, this counseling will be provided as a hybrid model with a combination of 4 in-person nutrition counseling sessions and 3 virtual dietary counseling sessions provided by a registered dietitian. In summary:

1. Intervention group will receive NUTRI-Beta foods basket + nutrition counseling (NUTRI-Beta dietary counseling) + standard insulin treatment (either insulin injections or insulin pump per patient preference)+ standard of care insulin therapy and use of a 24-hour continuous glucose monitor, and
2. Control group will receive the standard nutrition counseling per the American Dietary Association (ADA) Guidelines [2] + weekly grocery store gift cards + standard of care insulin therapy and use of a 24-hour continuous glucose monitor.

The NUTRI-Beta clinical trial study visits will include a total of 10 visits during the 24 weeks of the study: Screening visit (V0), baseline visit (enrolment visit= V1), nutrition counseling visit 2 (week 2 post enrollment), nutrition counseling visit 3 (V3-virtual, week 3), nutrition counseling visit 4 (V4-in person, week 4), nutrition counseling visit 5 (V5-virtual, week 6), nutrition counseling visit 6 (V6-in person, week 8), nutrition counseling visit 7 (V7-virtual, week 10), visit 8 ( 12 weeks after enrollment- end of nutrition intervention), and visit 9 (24 weeks after enrollment).

We expect that this nutrition intervention (NUTRI-Beta) will be acceptable to children with new diagnosis of clinical diabetes (stage 3 of T1D) and will improve their diet intake and quality, their nutrition status and may increase their likelihood of residual beta-cell function in the treatment group. Evaluation of the partial remission of T1D will be completed through the determination of the insulin dose-adjusted A1C (IDAA1C) and residual beta cell function through the measurement of peak C-peptide levels during a 2-hour mixed-meal tolerance test (MMTT) after 12 and 24 weeks of the nutrition intervention.

The treatment group is expected to have higher rates of partial remission of T1D measured by the IDAA1C, better diet quality, better glycemic metrics and reduced needs of total daily dose of insulin (TDD) (unit/kg/day).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willing and able to give assent and to have a parent or legal guardian to provide informed consent
2. Less or equal than 60 days from T1D diagnosis based on American Diabetes Association criteria, and metabolically stable per study physician assessment
3. Boys and girls (Any Tanner stage), 6-17 years of age, at time of enrollment visit
4. 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
5. 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
6. Capability to eat different types of food by mouth
7. Daily use of a 24-hour continuous glucose monitor by the time of the enrollment visit
8. Willing and being able to give assent and have a parent or legal guardian provide informed consent

Exclusion Criteria:

1. 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)
2. Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies to control hyperglycemia including immunosuppressive therapies
3. Chronic inflammatory or autoimmune diseases with exception of stable autoimmune thyroid disease
4. Children requiring enteral feeds or parenteral nutrition support
5. 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.
6. Use of glucocorticoids or other immunosuppressive agents within 30 days of T1D diagnosis
7. Use of medications known to influence glucose intolerance within 30 days of T1D diagnosis
8. 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
9. Prior diagnosis or positive screening of food sensory disorders
10. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation to the study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NUTRI-Beta Intervention Group; 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: seasonal fruits (containing high amounts of vitamin C and E); legumes,; nuts,; yogurt, and; seasonal vegetables (carotenoids, tomatoes, broccoli, celery, etc.).; 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 Counseling focused on anti-inflammatory foods; Other Names: NUTRI-Beta Intervention; Dietary supplement: Free weekly produce foods; Free weekly produce
Other: Standard of care nutrition counseling (MyHealthy plate model and ADA clinical guidelines); STANDARD OF CARE NUTRITION COUNSELING: A 12-week distribution of weekly grocery store gift cards of similar monetary value of the NUTRI-Beta food bag in addition to; MyPlate USDA model with similar frequency of nutrition counseling visits but following the American Dietary Association (ADA) Guidelines, and; Standard insulin treatment (either insulin injections or insulin pump per patient preference) and 24-hour continuous glucose monitor	Dietary supplement: Standard dietary counseling; Standard of Care therapy: Nutrition counseling per the ADA clinical guidelines and USDA MyPlate model; Other Names: Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight changes from baseline visit to the 12-week visit	Change in subject weight	12weeks
Weight changes from baseline visit to the 24-week visit	Change in subject weight	24 weeks
Weight Z-score changes from baseline visit to the 12 week visit	Change in subject weight z-score	12 weeks
Weight Z-score changes from baseline visit to the 24 week visit	Change in subject weight z-score	24 weeks
Height changes from baseline to the 12 week visit	Change in subject height	12 weeks
Height changes from baseline to the 24 week visit	Change in subject height	24 weeks
Height Z-score changes from baseline to the 12 week visit	Change in subject height z score	12 weeks
Height Z-score changes from baseline to the 24 week visit	Change in subject height z score	24 weeks
BMI Z-score changes from baseline to 12 weeks	Change in subject BMI z-score	12 weeks
BMI Z-score changes from baseline to 24 weeks	Change in subject BMI z-score	24 weeks
Height velocity changes from baseline visit to the 12-week visit	Change in subject height velocity	12 weeks
Height velocity changes from baseline visit to the 24-week visit	Change in subject height velocity	24 weeks
Percentage of time in range (TIR) glucose levels from baseline to 3 month intervention visit	Change in percentage of TIR glucose levels from baseline to 3 month intervention visit	3 months
Percentage of time in range (TIR) glucose levels from baseline to 6-month post intervention visit	Change in percentage of TIR glucose levels from baseline to 24-week visit	24 weeks
Percentage of time above range (TAR) glucose levels from baselines to 3 month intervention visit	Change in percentage of TAR glucose levels from baseline to 3 month intervention visit	3 months
Percentage of time below range (TBR) glucose levels from baselines to 3 month intervention visit	Change in percentage of TBR glucose levels from baseline to 3 month intervention visit	3 months
Percentage of time below range (TBR) glucose levels from baselines to 6 month post intervention visit	Change in percentage of TBR glucose levels from baseline to 6 month post intervention visit	6 months
Percentage of mean glucose level from baseline to 12-week visit	Change in percentage of mean blood glucose level from baseline to 12-week visit	12 weeks
Percentage of average glucose levels from baseline to 6 month post intervention visit	Change in percentage of average glucose levels from baseline to 6 month post intervention visit	6 months
Percentage of standard deviation of glucose levels from baseline to 3 month intervention visit	Change in percentage of standard deviation glucose levels from baseline to 3 month intervention visit	3 months
Percentage of standard deviation of glucose levels from baseline to 6 month post intervention visit	Change in percentage of standard deviation of glucose levels from baseline to 6 month post intervention visit	6 months
Percentage of coefficient of variation (CV) of glucose levels from baseline to 3 month intervention visit	Change in percentage of CV of glucose levels from baseline to 3 month intervention visit	3 months
Percentage of coefficient of variation (CV) of glucose levels from baseline to 6 month post intervention visit	Change in percentage of CV of glucose levels from baseline to 6 month post intervention visit	6 months
Percentage of glucose management index (GMI) of glucose levels from baseline to 3 month intervention visit	Change in percentage of GMI of glucose levels from baseline to 3 month intervention visit	3 months
Percentage of glucose management index (GMI) of glucose levels from baseline to 6 month post intervention visit	Change in percentage of GMI of glucose levels from baseline to 6 month post intervention visit	6 months
Percentage of hemoglobin A1C (HbA1C) of glucose levels from baseline to 3-month intervention visit	Change in percentage of HbA1C glucose levels from baseline to 3-month intervention visit	3 months
Percentage of hemoglobin A1C (HbA1C) of glucose levels from baseline to 6 month post intervention visit	Change in percentage of HbA1C glucose levels from baseline to 6 month post intervention visit	6 months
Dietary intake changes on daily total K- calories from baseline visit to 12 week visit	Change in dietary intake on daily total K-calories will be obtained through the use of the ASA24 dietary online tool, measuring daily total K-calories.	12 weeks
Dietary intake changes on daily total K- calories from baseline visit to 24 week visit	Change in dietary intake on daily total K-calories will be obtained through the use of the ASA24 dietary online tool, measuring daily total K-calories.	24 weeks
Macronutrient intake composition from baseline to 12 week visit	Change in macronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of macronutrients (carbohydrates, proteins, and fats)	12 weeks
Macronutrient intake composition from baseline to 24 week visit	Change in macronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of macronutrients (carbohydrates, proteins, and fats)	24 weeks
Micronutrient intake composition from baseline to 12 week visit	Change in micronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of micronutrients	12 weeks
Micronutrient intake composition from baseline to 24 week visit	Change in micronutrient intake composition will be obtained through the use of the ASA24 dietary online tool, measuring daily percentage of micronutrients	24 weeks
Changes in the baseline levels of carotenoids, vitamin C and vitamin E	Changes in levels of carotenoids, vitamin C and vitamin E from baseline to 12-week visit	12 weeks
Changes in the baseline levels of carotenoids, vitamin C and vitamin E	Changes in levels of carotenoids, vitamin C and vitamin E from baseline visit to 24-week visit	24 weeks
Changes on the levels of 25-hydroxy vitamin D	Changes on the baseline level of 25-hydroxy vitamin D level to the 12-week visit	12 weeks
Changes on the levels of 25-hydroxy vitamin D	Changes on the baseline level of 25-hydroxy vitamin D level to 24-week visit	24 weeks
Omega 3 index (O3i) levels changes during the clinical trial	Changes of baseline levels of Omega 3 index (O3i) to 12-week visit	12 weeks
Omega 3 index levels during clinical trial	Changes of Omega 3 index level from baseline visit to the 24-week study visit	24 weeks
Middle Upper Arm Circumference (MUAC) changes	Middle Upper Arm Circumference (MUAC) changes From enrollment visit to 12-week visit (end of nutrition intervention)	12 weeks
Middle Upper Arm Circumference (MUAC)	Middle Upper Arm Circumference (MUAC) changes from enrollment visit to 24-week visit (end of the study)	24 weeks
Healthy Eating Index (HEI) change from baseline to the 12-week visit	HEI ranges from 0-100, with an ideal score being 100.	12 weeks
Healthy Eating Index (HEI) change from baseline to the 24-week visit.	HEI ranges from 0-100, with an ideal score being 100.	24 weeks
Body Mass Index (BMI) changes from baseline to the 12 week visit	Change in subject BMI	12 weeks
Body Mass Index (BMI) changes from baseline to the 24 week visit	Change in subject BMI	24 weeks
Percentage of time above range (TAR) glucose levels from baseline to the 6 -month post intervention visit	Change in percentage of TAR glucose levels from baseline to 6 month post intervention visit	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve and peak C-peptide level determined by MMTT (Mixed Meal Tolerance Test)	Peak c-peptide levels from baseline over the course of 2 hours	2 hours
Change in the total daily dose of exogenous insulin (TDD) as units/kg/day from baseline to the 12-week visit	Change in TDD of insulin	12 weeks
Change in the total daily dose of exogenous insulin (TDD) as units/kg/day from baseline to the 24-week visit.	Change in TDD of insulin	24 weeks
Change in the IDAA1C from enrollment (baseline) visit to the 12-week study visit	Change in the IDAA1C	12 weeks
Change on the IDAA1C from enrollment (baseline) visit to the 24-week study visit	Change in the IDAA1C	24 weeks

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Penn State University
• Investigators: Principal Investigator: Lina Huerta Saenz, MD, FAAP, Pediatric Endocrinologist, Assistant Professor of Pediatrics, Penn State Health Milton Hershey Medical Center, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Children; Nutrition; Diabetes mellitus type 1; T1D; Youth; healthy eating; Nutrition Counseling; Nutrition Intervention; Healthy foods; Honeymoon phase; partial remission of diabetes; new diagnosis of type 1 diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STUDY00020631

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No