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Behavioural Intervention

Controlled Diets for Dietary Biomarker Identification in Healthy Adults (P1-SDBDC Trial)

N/A
Recruiting
Led By Marian L. Neuhouser, PhD, RD
Research Sponsored by Marian Neuhouser
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours
Awards & highlights

P1-SDBDC Trial Summary

This trial aims to identify and validate biomarkers to more accurately measure dietary intake than self-reporting. Participants will be fed controlled diets and blood/urine samples taken to identify biomarkers.

Who is the study for?
Healthy adults over 18, with a BMI of 18.5-39.9 kg/m2, who can visit the Fred Hutch campus 16 times for the study are eligible. Exclusions include those with certain gastrointestinal disorders, recent surgery or cancer treatment, substance use that they're unwilling to stop during the study, and various other health conditions and medication uses.Check my eligibility
What is being tested?
The trial is testing how well blood and urine biomarkers can measure diet by having participants eat controlled diets including beef/pinto beans or eggs/black beans. Researchers will analyze these biological samples to identify reliable dietary intake indicators.See study design
What are the potential side effects?
Since this is a dietary intervention involving common foods like beef, pinto beans, eggs, and black beans in healthy volunteers under controlled conditions, significant side effects are not anticipated beyond potential food allergies or intolerances.

P1-SDBDC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean area under the curve of 24-hour metabolite concentration for Beef
Mean area under the curve of 24-hour metabolite concentration for Black Bean
Mean area under the curve of 24-hour metabolite concentration for Egg
+5 more

P1-SDBDC Trial Design

6Treatment groups
Experimental Treatment
Group I: 6) Black bean then egg then half black bean and half eggExperimental Treatment1 Intervention
Group II: 5) Half egg and half black bean, then black bean then eggExperimental Treatment1 Intervention
Group III: 4) Egg then half Egg and half black bean then black beanExperimental Treatment1 Intervention
Group IV: 3) Pinto Bean then Beef then half pinto bean and half beefExperimental Treatment1 Intervention
Group V: 2) Half pinto bean and half beef then pinto bean then beefExperimental Treatment1 Intervention
Group VI: 1) Beef then half beef and half pinto bean then pinto beanExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Marian NeuhouserLead Sponsor
United States Department of Agriculture - National Institute of Food and Agriculture (USDA-NIFA)UNKNOWN
University of NebraskaOTHER
540 Previous Clinical Trials
1,144,705 Total Patients Enrolled

Media Library

Controlled feeding study of beef and/or pinto beans (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05580653 — N/A
Healthy Adults Research Study Groups: 1) Beef then half beef and half pinto bean then pinto bean, 2) Half pinto bean and half beef then pinto bean then beef, 3) Pinto Bean then Beef then half pinto bean and half beef, 4) Egg then half Egg and half black bean then black bean, 5) Half egg and half black bean, then black bean then egg, 6) Black bean then egg then half black bean and half egg
Healthy Adults Clinical Trial 2023: Controlled feeding study of beef and/or pinto beans Highlights & Side Effects. Trial Name: NCT05580653 — N/A
Controlled feeding study of beef and/or pinto beans (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05580653 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are slots still available for individuals to participate in this experiment?

"The data hosted on clinicaltrials.gov informs that, as of the last update made on November 21st 2022, this study has ceased to seek out prospective participants. Notwithstanding, there are 14 other medical trials presently taking in candidates."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Indiana
Pennsylvania
Other
What site did they apply to?
Fred Hutchinson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am fully capable of eating specific diets for extended periods of time and am interested in the findings of this dietary study.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Phase 1 Seattle Dietary Biomarkers Development Center
Marian Neuhouser 2023. "Phase 1 Seattle Dietary Biomarkers Development Center". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05580653.
~9 spots leftby Dec 2024
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