30 Participants Needed

Dietary Biomarkers Development for Healthy Adults

(P2-SDBDC Trial)

ML
SA
Overseen BySarah Altvater, MS, RD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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. Stool samples will be collected and archived.

Research Team

ML

Marian L. Neuhouser

Principal Investigator

Fred Hutchinson Cancer Center

JW

Johanna W. Lampe, PhD, RD

Principal Investigator

Fred Hutchinson Cancer Center

Eligibility Criteria

This trial is for healthy adults who can participate in controlled feeding studies. Specific eligibility criteria are not provided, but typically participants must be willing to follow dietary guidelines and provide biological samples.

Inclusion Criteria

Willing to come to the Fred Hutch campus 10 times during the study
BMI 18.5-39.9 kg/m2

Exclusion Criteria

I haven't taken any antibiotics in the last 6 months.
Pregnancy or lactation
Seated blood pressure >140/90 mmHg
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Controlled Feeding Period 1

Participants undergo a 2-day run-in of controlled feeding followed by a 7-day feeding period on either a higher or lower HEI-2020 diet

9 days

Washout

Participants undergo a washout period between feeding periods

7 days

Controlled Feeding Period 2

Participants undergo a second 2-day run-in of controlled feeding followed by a 7-day feeding period on the alternate HEI-2020 diet

9 days

Follow-up

Participants are monitored for biomarker identification and validation after the feeding periods

4 weeks

Treatment Details

Interventions

  • Higher HEI-2020 diet followed by lower HEI-2020 diet
  • Lower HEI-2020 diet followed by higher HEI-2020 diet
Trial Overview The study tests the effects of switching between higher and lower Healthy Eating Index (HEI-2020) diets on various health markers. Participants will have their diet altered twice, with blood, urine, and stool samples collected for analysis.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2: Lower HEI-2020 diet followed by higher HEI-2020 dietExperimental Treatment1 Intervention
Group II: Arm 1: Higher HEI-2020 diet followed by lower HEI-2020 dietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Marian Neuhouser

Lead Sponsor

Trials
2
Recruited
60+

University of Nebraska

Collaborator

Trials
563
Recruited
1,147,000+

United States Department of Agriculture - National Institute of Food and Agriculture (USDA-NIFA)

Collaborator

Trials
2
Recruited
60+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+
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