Phase 1 Seattle Dietary Biomarkers Development Center

Status Recruiting

Clinical Trial Summary

The Seattle Dietary Biomarker Development Center (S-DBDC) aims to advance the science of measuring dietary intake by identification and validation of dietary biomarkers that improve upon self-reported diet. To accomplish this mission, the Seattle DBDC will carry out controlled feeding studies in healthy human volunteers. Metabolomics assays will be conducted on blood and urine specimens collected during the feeding studies for biomarker identification.

Clinical Trial Description

The central mission of the Seattle Dietary Biomarker Development (DBDC) is to advance the science of measuring complex dietary exposures by rigorous identification and validation of dietary biomarkers that improve upon measurement error prone self-reported diet. To accomplish this mission, the Seattle DBDC will conduct a set of two, randomized, crossover, 3-period controlled feeding trials to develop metabolomics-based blood and urine biomarkers of 4 individual foods (1) beef and pinto beans or 2) eggs and black beans) and determine the dynamic ranges and half-lives of the urinary and blood-based dietary biomarkers. The two trials use the exact same sample protocol and study procedures and will be conducted successively. For each feeding trial, 15 healthy adults will complete three feeding periods in random order (all protein from beef (trial 1) or eggs (trial 2); 1/2 protein from beef (trial 1) or eggs (trial 2); and 1/2 protein from pinto beans (trial 1) or black beans (trial 2); all protein from pinto beans (trial 1) or black beans (trial 2)). Each feeding period will consist of a 2-day run-in of controlled feeding followed by a 7-day feeding period, with about a 7-day washout between feeding periods. Blood and urine specimens will be collected before, at the mid-point, and at the end of each feeding period. In addition, an all-day pharmacokinetic evaluation will be conducted for 2 of the 3 feeding periods (all beef and all pinto beans (trial 1); all eggs and all black beans (trial 2)). Stool samples will be collected before, and at the end of each feeding period and stored for future studies. The collected specimens will be used for study outcomes and archived for future studies. ;

Study Design

Related Conditions & MeSH terms

Healthy Adults

Clinical Trial Details

NCT number	NCT05580653
Study type	Interventional
Source	Fred Hutchinson Cancer Center
Contact	Sarah Altvater, MS, RD
Phone	206-667-7091
Email	fbs@fredhutch.org
Status	Recruiting
Phase	N/A
Start date	March 2, 2023
Completion date	June 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04677920` - The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology	N/A
Active, not recruiting	`NCT03312920` - Investigating Memory Retrieval Improvement in Healthy Subjects	N/A
Completed	`NCT03309072` - Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task	N/A
Completed	`NCT03289832` - Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin	N/A
Enrolling by invitation	`NCT06133530` - Human Milk Oligosaccharides (HMOs) and Gut Microbiota, Immune System in Antarctica	N/A
Completed	`NCT05141903` - Dietary Supplement With and Without a Probiotic and/or Antibiotic
Completed	`NCT01689259` - Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults	Phase 1
Completed	`NCT01187875` - Resistant Starch and Satiety	Phase 0
Completed	`NCT03312699` - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort	Phase 1
Completed	`NCT03319134` - Investigating the Neural Correlates in Memory Retrieval After HD-tDCS	N/A
Recruiting	`NCT04104360` - Galacto-oligosaccharides and Intestinal Activity	N/A
Completed	`NCT03228693` - Gene Expression and Biomarker Profiling of Keloid Skin	N/A
Active, not recruiting	`NCT04146532` - Aspirin Effects on Emotional Reactions	Early Phase 1
Completed	`NCT04206293` - A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers	N/A
Recruiting	`NCT06011018` - Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke	N/A
Completed	`NCT05093205` - STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS	Phase 1
Completed	`NCT04596709` - Investigation of Blood Glucose and Insulin Response After Intake of Vitalose	N/A
Completed	`NCT04272450` - Respiratory Muscle Strength in Different Age Groups
Completed	`NCT02044679` - Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions	N/A
Completed	`NCT01402973` - Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products	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.

Phase 1 Seattle Dietary Biomarkers Development Center — P1-SDBDC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms