Personalized Behavioral Nutrition for Type 2 Diabetes

Overseen By Jisook Ko, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Severe illness, Blindness, Psychiatric diseases, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude people on a diet different from the ADA recommended diet, so dietary changes might be required.

What data supports the effectiveness of this treatment for Type 2 Diabetes?

Research shows that personalized nutrition therapy, which considers individual health goals and cultural preferences, can improve blood sugar control in people with diabetes. Additionally, culturally tailored dietary interventions have been effective in improving nutritional knowledge and blood glucose levels, especially when adapted to specific cultural dietary patterns. ^{1 2 3 4 5}

Is Personalized Behavioral Nutrition safe for humans?

The available research suggests that personalized nutrition approaches, including those tailored for diabetes, are generally safe for humans. These interventions focus on improving dietary habits and managing diabetes through nutrition, which is a standard and safe practice in diabetes care. ^{4 6 7 8 9}

What makes the Personalized Behavioral Nutrition treatment unique for managing Type 2 Diabetes?

The Personalized Behavioral Nutrition treatment is unique because it tailors dietary interventions to individual needs using a machine-learning algorithm to predict how different foods affect blood sugar levels, unlike the standard 'one-size-fits-all' approach. It also incorporates cultural factors and uses mobile health technology to support behavior change, making it more adaptable to diverse lifestyles and preferences. ^{2 3 6 7 10}

What is the purpose of this trial?

The rapid growth rate and unique challenges as a new immigrant group call for a better understanding of the social and health needs of the older Asian Americans (AAs) population. Overwhelming numbers of AAs, a fast-growing first-generation immigrant group, suffer from type 2 diabetes (T2D) and its consequences of poorly controlled blood glucose. For the older AAs, there are higher prevalence rates, worse diabetes control, and higher rates of complications due to limited English proficiency and health literacy. Despite the evidence concerning the effects of dietary interventions on glycemic control by well-controlled feeding studies in mainstream Americans, a lack of clinical trials of culturally tailored interventions often imposes serious barriers to translate and implement such fruitful and innovative approaches in individuals from ethnic minority communities such as AAs. The proposed study will use a randomized, controlled design with a sample of 60 AAs aged 65 years or older. Metabolomics methodologies will be incorporated into this research to provide a global picture of metabolites' responses to personalized behavioral nutrition (PBN) intervention. The study results will obtain the necessary information to conduct a meaningful community-based clinical trial to test the effectiveness of PBN in improving dietary patterns and glycemic control in older AAs.

Research Team

Jisook Ko, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for older Asian Americans aged 65 or above with type 2 diabetes, an A1C level of at least 7.5%, living in Bexar County, and who own a smartphone. Participants must be willing to engage fully in the study and not be on any special diets other than the ADA recommended diet.

Inclusion Criteria

Living in the Bexar County area

You have a smartphone.

I have type 2 diabetes with an A1C level of 7.5% or higher in the last 6 months.

Exclusion Criteria

I do not have any health conditions that would prevent me from fully participating in the study.

I do not have blood conditions like hemolytic or sickle cell anemia.

I am unable to understand and agree to the study's details on my own.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week personalized behavioral nutrition intervention with digital self-monitoring for diet and blood glucose, and diabetes nutrition education.

4 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for changes in glycemic control, lipids profiles, weight, and metabolites profiles.

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• ADA-based nutrition education with digital self-monitoring
• Personalized Behavioral Nutrition (PBN) intervention group

Trial Overview The study tests a Personalized Behavioral Nutrition (PBN) intervention against standard ADA-based nutrition education using digital self-monitoring tools. It aims to see if PBN can improve dietary habits and blood sugar control among older Asian Americans with type 2 diabetes.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

This group will receive 4-week personalized behavioral nutrition intervention with digital self-monitoring for diet and blood glucose and diabetes nutrition education. Participants will discuss the personalized nutrition change goals and recommendations based on metabolic profiling for assessing dietary patterns.

Group II: Control group Active Control 1 Intervention

This group will receive 4-week diabetes nutrition education with digital self-monitoring for diet and blood glucose.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Asian Resource Center for Minority Aging Research (RCMAR)

Collaborator

Trials

1

Recruited

60+

The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)

Collaborator

Trials

1

Recruited

60+

Findings from Research

There is no one-size-fits-all meal plan for people with diabetes; nutrition therapy must be tailored to each individual's health goals, preferences, and circumstances.

Effective nutrition interventions should focus on a variety of minimally processed, nutrient-dense foods and provide practical tools for sustainable behavior change in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition therapy recommendations for the management of adults with diabetes. Evert, AB., Boucher, JL., Cypress, M., et al.[2022]

Diabetes management requires patients to actively change their behaviors, integrating blood glucose monitoring with personalized nutrition and physical activity plans.

A team approach that emphasizes individualized care, behavior change strategies, and regular follow-up can significantly enhance self-management and improve metabolic control in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition management and physical activity as treatments for diabetes. Wheeler, ML.[2019]

Nutrition interventions for Chinese populations with type 2 diabetes, both in China and as immigrants, often follow intensive lifestyle programs and show improvements in blood glucose control, indicating their efficacy.

Cultural adaptation of these interventions is crucial for success, particularly in Western countries, yet there is a need for more community-based trials and better documentation of dietary behaviors to fully understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Interventions for Type 2 Diabetes in Chinese Populations: A Scoping Review. Deng, F., Zhang, A., Chan, C.[2020]

A survey of 837 healthcare providers across Mexico, Taiwan, and the United States showed that 61% believe the transcultural Diabetes Nutrition Algorithm (tDNA) Patient Algorithm Therapy (PATh) can help address challenges in implementing medical nutrition therapy (MNT) for diabetes.

The majority of respondents (91%) had a positive impression of tDNA-PATh, with 83% indicating they would adopt it, suggesting that this culturally sensitive tool could effectively enhance MNT implementation in diverse clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The transcultural diabetes nutrition algorithm toolkit: survey and content validation in the United States, Mexico, and Taiwan. Hamdy, O., Marchetti, A., Hegazi, RA., et al.[2019]

A personalized diet tailored to patients with comorbidities like obesity and hypertension led to significant improvements in metabolic control indicators, including reduced body weight, waist circumference, and lower fasting glucose levels in a study of 39 patients over three months.

The dietary intervention also positively affected renal function, as evidenced by decreased urine albumin excretion and increased glomerular filtration rate in both microalbuminuria and macroalbuminuria groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of a personalized diet in the metabolic control and renal function of patients with type 2 diabetes]. Velázquez-López, L., Sil-Acosta, MJ., Goycochea-Robles, MV., et al.[2015]

Nutrition therapy has been shown to effectively improve glycemic control and reduce the risks associated with type 2 diabetes (T2D) and prediabetes, highlighting its importance in patient management programs.

A new transcultural diabetes-specific nutrition algorithm (tDNA) has been developed to adapt dietary recommendations for diverse cultures, aiming to enhance the implementation of nutrition therapy globally and ultimately reduce the burden of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes-specific nutrition algorithm: a transcultural program to optimize diabetes and prediabetes care. Mechanick, JI., Marchetti, AE., Apovian, C., et al.[2022]

The Personal Diet Study is investigating the effectiveness of two dietary interventions for weight loss in individuals with prediabetes and type 2 diabetes: a standard low-fat diet and a personalized diet based on machine-learning predictions of glycemic response.

The study will assess changes in body weight, body composition, and resting energy expenditure over a 6-month intervention period, followed by a 6-month observation period to evaluate the maintenance of weight loss, utilizing mobile health technology for behavioral support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes. Popp, CJ., St-Jules, DE., Hu, L., et al.[2022]

The activity-based personalized nutrition education (APNE) program significantly improved fasting blood glucose, postprandial blood glucose, and glycated hemoglobin levels in middle-aged and older patients with type 2 diabetes after 3 months, while the control group showed no such improvements.

Participants in the APNE group not only adhered more closely to a balanced diet but also made healthier food choices, such as reducing high-fat food intake and increasing consumption of fruits and vegetables, demonstrating the program's effectiveness in changing dietary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Activity-Based Personalized Nutrition Education on Dietary Behaviors and Blood Parameters in Middle-Aged and Older Type 2 Diabetes Korean Outpatients. Yang, SH., Chung, HK., Lee, SM.[2020]

Personalized nutrition (PN) is defined as a field that uses individual differences to create nutrition strategies aimed at preventing and managing diseases while optimizing health, emphasizing the need for a clear consensus to enhance research and clinical practice.

The field of PN can be divided into three key areas: science and data, education and training, and guidance and therapeutics, which together help healthcare professionals tailor nutrition interventions to individual needs and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. Bush, CL., Blumberg, JB., El-Sohemy, A., et al.[2021]

Personalized nutrition (PN) is more effective than conventional diets in improving metabolic health in obese and diabetic patients, as it takes into account individual genetic and microbiome differences.

Research indicates that understanding gene-environment interactions and gut microbiome patterns can enhance dietary interventions, leading to better management of obesity and diabetes-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The roles of personalized nutrition in obesity and diabetes management: a review. Zeinalian, R., Ahmadikhatir, S., Esfahani, EN., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nutrition therapy recommendations for the management of adults with diabetes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nutrition management and physical activity as treatments for diabetes. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Nutrition Interventions for Type 2 Diabetes in Chinese Populations: A Scoping Review. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The transcultural diabetes nutrition algorithm toolkit: survey and content validation in the United States, Mexico, and Taiwan. [2019]

5. Mexico pubmed.ncbi.nlm.nih.gov

[Effect of a personalized diet in the metabolic control and renal function of patients with type 2 diabetes]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetes-specific nutrition algorithm: a transcultural program to optimize diabetes and prediabetes care. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of Activity-Based Personalized Nutrition Education on Dietary Behaviors and Blood Parameters in Middle-Aged and Older Type 2 Diabetes Korean Outpatients. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The roles of personalized nutrition in obesity and diabetes management: a review. [2023]