Nutrition for Precision Health, Powered by the All of Us

Status Recruiting

Clinical Trial Summary

The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: - How does varying foods and eating patterns impact one's biological and physiological responses? - In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? - Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: - Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. - Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. - Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured.

Clinical Trial Description

The NPH study design includes three modules: Module 1, a study of participants' dietary intake; Module 2, a randomized crossover trial with three dietary interventions among participants in a community-dwelling setting; and Module 3, a similar trial to Module 2 except with participants in residence, all detailed in the following text. Briefly, Module 1 will observe participants for 8-10 days while consuming their usual diet. Modules 2 and 3 will include 3 dietary interventions, each administered for 14 days, followed by a washout period between each diet. The study will be conducted at multiple sites managed by 6 clinical centers throughout the United States. An interdisciplinary team of clinical nutrition research experts will evaluate dietary assessment methods, microbial metagenomics and metatranscriptomics, targeted and untargeted metabolomics, computational and data science to advance our current understanding of nutrition which will inform personalized nutrition recommendations. The resulting artificial intelligence (AI) algorithms to predict individual responses to food will provide a foundation to create customized dietary approaches to optimize short- and long-term health. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05701657
Study type	Interventional
Source	RTI International
Contact	Carolyn P Huitema, MS
Phone	833-947-2583
Email	info@nutritionforprecisionhealth.org
Status	Recruiting
Phase	N/A
Start date	April 14, 2023
Completion date	January 31, 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04025099` - Internal Cues Versus External Cues for Eating and Activity	N/A
Recruiting	`NCT06094049` - Acceptability of Folic Acid and Vitamin B12 Fortified Meals
Completed	`NCT03720314` - Microbiota Profiling in IBS
Completed	`NCT03334266` - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months	N/A
Recruiting	`NCT02894931` - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity	N/A
Completed	`NCT02559076` - The Eat Right Emirates Healthy Lifestyle Study	N/A
Completed	`NCT05502445` - The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People	N/A
Active, not recruiting	`NCT04308473` - Analysis of MicroBial Metabolites After Eating Refined Food	N/A
Completed	`NCT04082247` - Healthy Children 2021 Study in Childcare Centers	N/A
Recruiting	`NCT05157815` - Study to Investigate the Effect of Dietary Fibre Supplementation on Long-term Glucose Control in Prediabetic Subjects	N/A
Active, not recruiting	`NCT05607745` - Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study	N/A
Completed	`NCT06045845` - Effects of Beet Juice and Diet in Female Rowers	N/A
Completed	`NCT03775889` - Engaging School and Family in Navajo Gardening for Health	N/A
Not yet recruiting	`NCT02910128` - Childhood Obesity Prevention Trough Education Innovation in Primary School: A Quasi-experimental Trial	N/A
Completed	`NCT03189979` - Club Fit: Physical Activity and Healthy Eating at an After School Program	N/A
Completed	`NCT02572479` - Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS)
Completed	`NCT02102763` - Greek Childhood Obesity (GRECO) Study	N/A
Completed	`NCT04632771` - Nutritional Status and Bouillon Use in Northern Ghana
Recruiting	`NCT03500458` - Impact of Sleep Extension in Adolescents	N/A
Completed	`NCT03673267` - Nutricity: A Pilot Study to Improve Parental Nutrition Literacy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.