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Type 1 DiabetesNUTRI-BetaNCT06640478

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

A study testing NUTRI-Beta Counseling, Standard dietary counseling and Free weekly produce foods in people with Type 1 Diabetes, run by Milton S. Hershey Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
NUTRI-Beta Counseling, Standard dietary counseling and Free weekly produce foods
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
20 Nov 2024to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Penn State Health Children's

    Hershey, Pennsylvania, 17033

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: 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.

Read more

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
Read the 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).

Conditions
Type 1 Diabetes
Being tested
NUTRI-Beta Counseling, Standard dietary counseling, Free weekly produce foods
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
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NUTRI-Beta CounselingOther

    Also called NUTRI-Beta Intervention

    Dietary Counseling focused on anti-inflammatory foods

  • Standard dietary counselingDietary supplement

    Also called Standard

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

  • Free weekly produce foodsDietary supplement

    Free weekly produce

Study groups in NCT06640478
Study groupRoleWhat they receive
NUTRI-Beta Intervention GroupActive comparatorWe 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
Receives: Other: NUTRI-Beta Counseling; Dietary Supplement: Free weekly produce foods
Standard of care nutrition counseling (MyHealthy plate model and ADA clinical guidelines)OtherSTANDARD 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
Receives: Dietary Supplement: Standard dietary counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rates

    Number of subjects screened over the course of the study

    Measured: 6 months

  2. Enrollment rates

    Number of subjects participating over the course of the study

    Measured: 6 months

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

    Number of months necessary to meet recruitment goals

    Measured: 6 months

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

    Number of subjects screened to meet enrollment goals

    Measured: 6 months

  5. Number of participants who completed the 12-week intervention

    Number of subjects completing the intervention

    Measured: 12 weeks

  6. 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

    Measured: 12 weeks

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

    Number of subjects completing the MMTT at baseline

    Measured: Baseline

  8. 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

    Measured: 12 weeks

  9. 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

    Measured: 24 weeks

Secondary outcomes (46)

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

    HEI ranges from 0-100, with an ideal score being 100.

    Measured: 12 weeks

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

    HEI ranges from 0-100, with an ideal score being 100.

    Measured: 24 weeks

  3. Weight changes from baseline visit to the 12-week visit

    Change in subject weight

    Measured: 12weeks

  4. Weight changes from baseline visit to the 24-week visit

    Change in subject weight

    Measured: 24 weeks

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

    Change in subject weight z-score

    Measured: 12 weeks

  6. Weight Z-score changes from baseline visit to the 24 week visit

    Change in subject weight z-score

    Measured: 24 weeks

  7. Height changes from baseline to the 12 week visit

    Change in subject height

    Measured: 12 weeks

  8. Height changes from baseline to the 24 week visit

    Change in subject height

    Measured: 24 weeks

  9. Height Z-score changes from baseline to the 12 week visit

    Change in subject height z score

    Measured: 12 weeks

  10. Height Z-score changes from baseline to the 24 week visit

    Change in subject height z score

    Measured: 24 weeks

  11. Body Mass Index (BMI) changes from baseline to the 12 week visit

    Change in subject BMI

    Measured: 12 weeks

  12. Body Mass Index (BMI) changes from baseline to the 24 week visit

    Change in subject BMI

    Measured: 24 weeks

  13. BMI Z-score changes from baseline to 12 weeks

    Change in subject BMI z-score

    Measured: 12 weeks

  14. BMI Z-score changes from baseline to 24 weeks

    Change in subject BMI z-score

    Measured: 24 weeks

  15. Height velocity changes from baseline visit to the 12-week visit

    Change in subject height velocity

    Measured: 12 weeks

  16. Height velocity changes from baseline visit to the 24-week visit

    Change in subject height velocity

    Measured: 24 weeks

  17. 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

    Measured: 3 months

  18. 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

    Measured: 24 weeks

  19. 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

    Measured: 3 months

  20. 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

    Measured: 6 months

  21. 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

    Measured: 3 months

  22. 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

    Measured: 6 months

  23. 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

    Measured: 12 weeks

  24. 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

    Measured: 6 months

  25. 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

    Measured: 3 months

  26. 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

    Measured: 6 months

  27. 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

    Measured: 3 months

  28. 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

    Measured: 6 months

  29. 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

    Measured: 3 months

  30. 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

    Measured: 6 months

  31. 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

    Measured: 3 months

  32. 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

    Measured: 6 months

  33. 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.

    Measured: 12 weeks

  34. 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.

    Measured: 24 weeks

  35. 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)

    Measured: 12 weeks

  36. 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)

    Measured: 24 weeks

  37. 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

    Measured: 12 weeks

  38. 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

    Measured: 24 weeks

  39. 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

    Measured: 12 weeks

  40. 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

    Measured: 24 weeks

  41. 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

    Measured: 12 weeks

  42. Changes on the levels of 25-hydroxy vitamin D

    Changes on the baseline level of 25-hydroxy vitamin D level to 24-week visit

    Measured: 24 weeks

  43. Omega 3 index (O3i) levels changes during the clinical trial

    Changes of baseline levels of Omega 3 index (O3i) to 12-week visit

    Measured: 12 weeks

  44. Omega 3 index levels during clinical trial

    Changes of Omega 3 index level from baseline visit to the 24-week study visit

    Measured: 24 weeks

  45. Middle Upper Arm Circumference (MUAC) changes

    Middle Upper Arm Circumference (MUAC) changes From enrollment visit to 12-week visit (end of nutrition intervention)

    Measured: 12 weeks

  46. Middle Upper Arm Circumference (MUAC)

    Middle Upper Arm Circumference (MUAC) changes from enrollment visit to 24-week visit (end of the study)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start20 Nov 2024
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06640478
Sponsor's protocol ID
STUDY00020631
Acronym
NUTRI-Beta
Status last verified
Aug 2026
First submitted
10 Oct 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NUTRI-Beta Counseling, Standard dietary counseling and Free weekly produce foods in people with Type 1 Diabetes, run by Milton S. Hershey Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rates (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06640478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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