Dietary Interventions for Diabetes Prevention
Recruiting in Palo Alto (17 mi)
Overseen ByMichael P Snyder, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Diabetogenic, Weight loss
Disqualifiers: Major organ disease, Hypertension, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial aims to prevent diabetes by creating personalized diet plans based on individual differences in how people develop the disease. It focuses on people with pre-diabetes or diabetes and uses biomarkers to diagnose and tailor diets early.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on diabetogenic medications (medications that can cause diabetes), you may not be eligible to participate.
What data supports the effectiveness of the treatment Precision Diets, Personalized Nutrition, Precision Nutrition for diabetes prevention?
Research suggests that precision nutrition, which tailors dietary advice based on individual characteristics like genetics and metabolism, can potentially be more effective in preventing type 2 diabetes compared to traditional approaches. Studies have shown that personalized dietary interventions can improve glycemic control (blood sugar management) and help manage risk factors for diabetes.
12345Is precision nutrition safe for humans?
The research on precision nutrition, which tailors dietary advice based on individual characteristics like genetics and metabolism, does not report any specific safety concerns for humans. However, more studies are needed to confirm its safety and effectiveness compared to traditional nutrition approaches.
23678How does the treatment Precision Diets differ from other treatments for diabetes prevention?
Precision Diets, or Precision Nutrition, is unique because it tailors dietary recommendations to an individual's genetic background, metabolic profile, and gut microbiome, unlike traditional one-size-fits-all approaches. This personalized strategy aims to optimize dietary response and improve health outcomes by considering personal characteristics and using advanced technologies like genomics and metabolomics.
2391011Eligibility Criteria
This trial is for adults over 18 who are not pregnant and do not have any major organ diseases, uncontrolled high blood pressure, or conditions affecting nutrient absorption like celiac disease. It's also important that participants haven't had significant weight changes recently, aren't heavy alcohol users, don't use weight loss drugs or follow specific diets, and haven't undergone bariatric surgery.Inclusion Criteria
Not be pregnant, if female;
I am 18 years old or older.
Exclusion Criteria
Any medical condition that physicians believe would interfere with study participation or evaluation of results.
I am mentally capable and can understand and follow the study's requirements.
I do not have major organ disease, uncontrolled high blood pressure, am not pregnant or breastfeeding, do not use certain medications, and have not had significant weight changes or surgery for weight loss.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Metabolic Testing
Participants undergo metabolic tests including the Oral Glucose Tolerance Test, Insulin Sensitivity Test, and Isoglycemic Intravenous Glucose Infusion
4-8 weeks
3 visits (in-person)
Dietary Monitoring
Participants follow their own diet while using the CGM and test standardized foods
8-12 weeks
2 visits (in-person), 1 visit (virtual)
Dietary Counseling
Participants are counseled on reducing foods that cause glucose spikes and on macronutrient composition
8-12 weeks
2 visits (in-person)
Follow-up
Participants are monitored for changes in glycemic control and metabolic subphenotype classification
3 years
Participant Groups
The study aims to understand how different people develop pre-diabetes and diabetes by looking at their individual physiological differences. Researchers will try to find biomarkers for early diagnosis and create personalized diet plans to prevent the onset of diabetes more effectively.
1Treatment groups
Experimental Treatment
Group I: Optimizing Diet for Glycemic ControlExperimental Treatment1 Intervention
Phase 1: Metabolic testing will include 3 metabolic tests:
1. The Oral Glucose Tolerance Test. The participant will wear the CGM while undergoing the OGTT + will be asked to repeat the test at home twice.
2. The Insulin Sensitivity Test (Steady State Plasma Glucose). This test is designed to measure how well cells remove glucose from the blood in response to insulin.
3. The Isoglycemic Intravenous Glucose Infusion (IIGI). This test is designed to measure the incretin hormone effect.
Phase 2: Participants follow their own diet while using the CGM. Participants are provided with 5-10 standardized foods to test during this phase.
Phase 3: Participants are provided with additional standardized foods and counseled to continue their own diet during this phase.
Phase 4: Participants are counseled on reducing or limiting the foods that caused glucose spikes and they are also counseled on macronutrient composition of their diet based on lipid profile.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
National Human Genome Research Institute (NHGRI)Collaborator
References
Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. [2022]To investigate the superiority of individualized dietary advice based on dietary assessment for patients with type 2 diabetes.
Precision nutrition for prevention and management of type 2 diabetes. [2022]Precision nutrition aims to prevent and manage chronic diseases by tailoring dietary interventions or recommendations to one or a combination of an individual's genetic background, metabolic profile, and environmental exposures. Recent advances in genomics, metabolomics, and gut microbiome technologies have offered opportunities as well as challenges in the use of precision nutrition to prevent and manage type 2 diabetes. Nutrigenomics studies have identified genetic variants that influence intake and metabolism of specific nutrients and predict individuals' variability in response to dietary interventions. Metabolomics has revealed metabolomic fingerprints of food and nutrient consumption and uncovered new metabolic pathways that are potentially modified by diet. Dietary interventions have been successful in altering abundance, composition, and activity of gut microbiota that are relevant for food metabolism and glycaemic control. In addition, mobile apps and wearable devices facilitate real-time assessment of dietary intake and provide feedback which can improve glycaemic control and diabetes management. By integrating these technologies with big data analytics, precision nutrition has the potential to provide personalised nutrition guidance for more effective prevention and management of type 2 diabetes. Despite these technological advances, much research is needed before precision nutrition can be widely used in clinical and public health settings. Currently, the field of precision nutrition faces challenges including a lack of robust and reproducible results, the high cost of omics technologies, and methodological issues in study design as well as high-dimensional data analyses and interpretation. Evidence is needed to support the efficacy, cost-effectiveness, and additional benefits of precision nutrition beyond traditional nutrition intervention approaches. Therefore, we should manage unrealistically high expectations and balance the emerging field of precision nutrition with public health nutrition strategies to improve diet quality and prevent type 2 diabetes and its complications.
Precision Nutrition to Improve Risk Factors of Obesity and Type 2 Diabetes. [2023]Existing dietary and lifestyle interventions and recommendations, to improve the risk factors of obesity and type 2 diabetes with the target to mitigate this double global epidemic, have produced inconsistent results due to interpersonal variabilities in response to these conventional approaches, and inaccuracies in dietary assessment methods. Precision nutrition, an emerging strategy, tailors an individual's key characteristics such as diet, phenotype, genotype, metabolic biomarkers, and gut microbiome for personalized dietary recommendations to optimize dietary response and health. Precision nutrition is suggested to be an alternative and potentially more effective strategy to improve dietary intake and prevention of obesity and chronic diseases. The purpose of this narrative review is to synthesize the current research and examine the state of the science regarding the effect of precision nutrition in improving the risk factors of obesity and type 2 diabetes.
Research charting a course for evidence-based clinical dietetic practice in diabetes. [2010]Nutrition and lifestyle interventions have been a critical component in three of the four largest clinical trials that focused on diabetes in the past two decades. Evidence of the effectiveness of nutrition and lifestyle interventions with resepect to achieving diabetes-related outcomes for diabetes prevention and a reduction in diabetes complications for people with diabetes is clearly mounting. The Diabetes Control and Complications Trial (1983-1993), the Diabetes Prevention Program (1996-2001) and the Look AHEAD (Action for Health in Diabetes) Trial (2001-2012) have been providing key evidence for the dietitian's role in delivering effective nutrition and lifestyle interventions for people with prediabetes, type 1 and type 2 diabetes. The dietitians in these multicentre efficacy trials contributed to this evidence base by expanding their roles beyond implementing the protocol defined goal-based nutrition and lifestyle interventions to conducting ancillary research and using problem-solving strategies that tailor counselling approaches toward participants' barriers to goal achievement. As lifestyle coaches and case managers, dietitians had the opportunity to work with the same group of study participants over extended periods of time and use their clinical and research expertise to uncover important insights and strategies that helped achieve clinical goals related to glycaemia control, weight loss and activity. The present review will 'chart the course' of how the evidence base for nutrition and lifestyle interventions emanated from these trials and discuss the implications for clinical dietetic practice. Dietitians can use insights gleaned from these experiences with the research process to expand their roles and guide cutting edge evidence-based clinical dietetic practice in diabetes.
Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. [2019]The translation of the growing increase of findings emerging from basic nutritional science into meaningful and clinically relevant dietary advices represents nowadays one of the main challenges of clinical nutrition. From nutrigenomics to deep phenotyping, many factors need to be taken into account in designing personalized and unbiased nutritional solutions for individuals or population sub-groups. Likewise, a concerted effort among basic, clinical scientists and health professionals will be needed to establish a comprehensive framework allowing the implementation of these new findings at the population level. In a world characterized by an overwhelming increase in the prevalence of obesity and associated metabolic disturbances, such as type 2 diabetes and cardiovascular diseases, tailored nutrition prescription represents a promising approach for both the prevention and management of metabolic syndrome. This review aims to discuss recent works in the field of precision nutrition analyzing most relevant aspects affecting an individual response to lifestyle/nutritional interventions. Latest advances in the analysis and monitoring of dietary habits, food behaviors, physical activity/exercise and deep phenotyping will be discussed, as well as the relevance of novel applications of nutrigenomics, metabolomics and microbiota profiling. Recent findings in the development of precision nutrition are highlighted. Finally, results from published studies providing examples of new avenues to successfully implement innovative precision nutrition approaches will be reviewed.
Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. [2023]Personalized nutrition (PN) behavior-change interventions are being used increasingly in attempts to improve dietary intake; however, the impact of PN advice on improvements in dietary intake has not been reviewed systematically. The aim of this systematic review was to evaluate the effect of PN advice on changes in dietary intake compared with generalized advice in healthy adults. Three databases (EMBASE, PubMed, and CINAHL) were searched between 2009 and 2020 for randomized controlled trials (RCTs) that tested the effect of PN and tailored advice based on diet, phenotype, or genetic information. The Evidence Analysis Library Quality Criteria checklist was used to conduct a risk-of-bias assessment. Information on intervention design and changes in nutrients, foods, and dietary patterns was extracted from the 11 studies meeting the inclusion criteria. Studies were conducted in the United States, Canada, or Europe; reported outcomes on 57 to 1488 participants; and varied in follow-up duration from 1 to 12 mo. Five studies incorporated behavior-change techniques. The risk of bias for included studies was low. Overall, the available evidence suggests that dietary intake is improved to a greater extent in participants randomly assigned to receive PN advice compared with generalized dietary advice. Additional well-designed PN RCTs are needed that incorporate behavior-change techniques, a broader range of dietary outcomes, and comparisons between personalization based on dietary, biological, and/or lifestyle information.
Harnessing the gut microbiota to promote metabolic health. [2021]Precision medicine has become the mainstay of modern therapeutics, especially for neoplastic disease, but this paradigm does not commonly prevail in dietary planning. Compelling evidence suggests that individual features, including the structure and function of the gut microbiota, contribute to harvesting and metabolizing energy from food, and thereby modulate the host metabolic phenotype and glucose homeostasis. Here, the concept of precision to dietary planning is highlighted by demonstrating the role of the microbiota in glucose intolerance in response to noncaloric artificial sweeteners, and by linking the microbiota and other host features to postprandial increases in blood glucose. These findings highlight the heterogeneity that exists among humans, which translates into divergent metabolic responses to similar food and warrants the adoption of next-generation sequencing technologies and advanced bioinformatics to revolutionize nutrition studies, laying the groundwork for an individually focused tailor-made practice.
A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet® study. [2023]Managing nutrition and lifestyle practices, nutrition phenotypes, and the genome forms the foundation of precision nutrition. Precision nutrition focuses on metabolic variability among individuals, and one approach to achieving its goals is to integrate gene-based nutrition and lifestyle recommendations in nutrition practice. However, scientific evidence proving the effectiveness of such recommendations is limited. This study will examine whether providing nutrition and lifestyle recommendations based on individual genotype can lead to better weight loss, along with reduction in body mass index (BMI), waist circumference, and body fat percentage among overweight and obese adults.
[Precision nutrition: handle with care.] [2020]Diet is a fundamental risk determinant for the majority of chronic diseases in the western world. Precision nutrition aims to tailor nutritional interventions, through the availability of new technologies in the "omic" area. This knowledge has enormous potential, but there are currently no validated results in the clinical setting. Precision nutrition is currently a hypothetical approach to predicting, preventing and treating some of the major chronic diseases in the individual. Therefore, extreme caution is needed before announcing the beginning of a new era.
Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. [2019]The primary focus of public health recommendations related to the prevention of food-related chronic disease has been on the adoption of healthy dietary patterns; however, implementation has been challenging. There has been increasing recognition that an individual's diet and environment may impact disease susceptibility by affecting the expression of genes involved in critical metabolic pathways. Precision nutrition (PN) has emerged to translate discoveries about diversity in nutrient metabolism between subgroups and the inter-individual variability in the responses to dietary interventions. The overarching goals of PN are to deliver individualized, actionable dietary therapy based on an individual's nutritional phenotype, created from the integration of genetics, metabolic profile, and environmental factors in order to prevent and treat chronic disease. This review addresses the developments of genome- and omic-driven PN and how they have been used to prevent and treat disease, as well as how they might be integrated into broader clinical practice.
Research navigating the course of clinical practice in diabetes. [2005]Three of the four largest and, arguably, most important long-term clinical trials focusing on diabetes in the past 2 decades have had medical nutrition therapy (MNT) as a major element of their experimental therapies: the Diabetes Control and Complications Trial and its follow-up study the Epidemiology of Diabetes Interventions and Complications Study, the Diabetes Prevention Program, and the Look AHEAD (Action for Health in Diabetes) study. The important features of these studies, their major results, and implications for current and future practice of MNT in the prevention and treatment of diabetes are delineated. The evidence suggests that dietetics professionals have an increasingly important role in the early initiation of MNT in the treatment and prevention of diabetes and in establishing the long-term relationships required to shape behavior and sustain the lifestyle habits that translate into significant reductions in the incidence of diabetes-related health outcomes and improved cost-effectiveness over time.