Dietary Biomarkers Development for Healthy Adults

(P2-SDBDC Trial)

Overseen By Sarah Altvater, MS, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marian Neuhouser

Must not be taking: Antibiotics, Anti-inflammatories, Weight-loss aids

Disqualifiers: Pregnancy, Gastrointestinal disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve dietary measurement by developing new methods to track dietary intake through the body. Participants will follow two different diets that vary in quality: the Higher HEI-2020 diet and the Lower HEI-2020 diet, in alternating order. The focus is on identifying dietary biomarkers (biological indicators) through blood, urine, and stool samples. Interested participants should be healthy adults willing to visit the Fred Hutch campus ten times and adhere to specific eating plans. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance dietary tracking methods for everyone.

Do I need to stop taking my current medications for the trial?

The trial requires participants to stop taking certain over-the-counter supplements and weight-loss aids during feeding periods. If you are on specific prescription medications, you may not be eligible to participate. The protocol does not specify a general requirement to stop all current medications, but it does mention some restrictions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that diets with high scores on the Healthy Eating Index (HEI-2020) are linked to health benefits, such as a lower risk of some cancers. Consuming plenty of fruits, vegetables, and whole grains can promote good health.

Although specific safety data on HEI-2020 diets is lacking, they are based on general healthy eating guidelines that many people already follow. These diets emphasize nutritious foods and limit less healthy ones, suggesting they are safe and well-tolerated for most individuals.

Both higher and lower HEI-2020 diets aim to improve dietary quality. No reports of serious side effects have emerged from following these diets. They focus on natural foods that are part of a balanced diet, which is generally considered safe and healthy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different dietary patterns, specifically the Health Eating Index (HEI)-2020 diets, can serve as biomarkers for health in adults. Unlike typical approaches that focus on specific nutrients or supplements, this study looks at the overall dietary patterns and their potential health impacts. By comparing higher and lower HEI-2020 diets, researchers hope to uncover valuable insights into how comprehensive dietary changes can influence health outcomes, paving the way for more holistic dietary recommendations in the future.

What evidence suggests that this trial's treatments could be effective for developing dietary biomarkers?

This trial will compare two dietary interventions: one group will follow a higher HEI-2020 diet first, then a lower HEI-2020 diet, while another group will do the reverse. Research has shown that a healthier diet, as measured by the Healthy Eating Index (HEI-2020), can lower the risk of colorectal cancer by 31%. Eating according to these guidelines may reduce the chance of developing this type of cancer. In contrast, a diet with a lower HEI-2020 score, which does not closely follow dietary guidelines, might not offer these protective benefits. The HEI-2020 is a tool that evaluates how well a diet aligns with recommended eating habits. While healthier eating can improve overall health, the specific benefits depend on adherence to these guidelines. ^{2 3 4 6 7}

Who Is on the Research Team?

Johanna W. Lampe, PhD, RD

Principal Investigator

Fred Hutchinson Cancer Center

Marian L. Neuhouser

Principal Investigator

Fred Hutchinson Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm 2: Lower HEI-2020 diet followed by higher HEI-2020 diet Experimental Treatment 1 Intervention

Group II: Arm 1: Higher HEI-2020 diet followed by lower HEI-2020 diet Experimental Treatment 1 Intervention

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11521706/

The Healthy Eating Index 2020 components contributed ... HEI‐2020 scores range from 0 to 100, with higher HEI scores reflecting higher diet quality. The details of the HEI‐2020 and its components have been described ...

2. fns.usda.gov fns.usda.gov/cnpp/healthy-eating-index-hei

Healthy Eating Index (HEI) The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations and dietary patterns

3. sciencedirect.com sciencedirect.com/science/article/pii/S187778212500030X

Healthy Eating Index (HEI-2020) score and colorectal ... Higher HEI-2020 scores, representing alignment with dietary guidelines, are associated with a 31% reduced risk of colorectal cancer.

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-18630-7

Diet quality as assessed by the healthy eating index-2020 ... The objective of this study is to examine dietary quality – using Healthy Eating Index (HEI – 2020) and its 13 components, among current, former, and never ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1519607/full

The healthy eating index may not be an appropriate ... Conclusion: Higher total and component scores of the HEI-2020 do not uniformly confer a lower mortality risk for BC survivors. The HEI-2020 may not be an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524328/

Healthy Eating Index-2020: Review and Update Process to ... The purpose of this paper is to share the process for reviewing, updating, and developing the most recent version of the Healthy Eating Index (HEI) for ages ...

7. nature.com nature.com/articles/s41598-025-88317-5

Association between Healthy Eating Index-2020 ... The findings indicate that higher HEI-2020 and aMED scores are significantly associated with reduced risks of GI cancers. Mediation analyses ...