Controlled Diets for Dietary Biomarker Identification in Healthy Adults

(P1-SDBDC Trial)

Overseen by Marian L. Neuhouser

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Marian Neuhouser

Must not be taking: Diuretics, Steroids, Opiates, others

Disqualifiers: Gastrointestinal disorders, Cancer, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial involves healthy adults eating specific foods like beef, beans, and eggs to help researchers find unique markers in their blood and urine. These markers will help scientists accurately measure dietary intake.

Will I have to stop taking my current medications?

The trial requires that participants stop taking certain medications, including diuretics, steroids, opiates, and some psychiatric and anti-lipid medications. Study staff will review your medications to determine eligibility, so you may need to stop taking some of your current medications.

What data supports the effectiveness of the treatment involving controlled feeding of beef and/or pinto beans?

Research shows that consuming dry beans, like pinto beans, may help reduce the risk of certain cancers, such as colon and breast cancer, by affecting cancer-related processes in the body. This suggests that including pinto beans in a diet could have health benefits related to cancer prevention. ^{1 2 3 4 5}

Is it safe for humans to consume controlled diets including beef, pinto beans, eggs, and black beans?

Research indicates that beans, including pinto and black beans, are generally safe for human consumption and provide nutritional benefits like protein and fiber. However, some people may experience intestinal gas from beans, and it's important to ensure a balanced diet to maintain nutrient levels. ^{2 5 6 7 8}

How is the controlled feeding study of beef and pinto beans unique compared to other treatments?

This treatment is unique because it uses a controlled diet to identify dietary biomarkers, which are indicators in the body that reflect food intake. Unlike other treatments that may focus on single nutrients, this study evaluates the combined effects of specific foods like beef and pinto beans, potentially offering a more comprehensive understanding of diet-related health impacts. ^{4 9 10 11 12}

Research Team

Johanna W. Lampe, PhD, RD

Principal Investigator

Fred Hutchinson Cancer Center

Marian L. Neuhouser

Principal Investigator

Fred Hutchinson Cancer Center

Eligibility Criteria

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.

Exclusion Criteria

I have a history of serious gut disorders like Crohn's or celiac disease.

Pregnant or lactating

Use of illicit drugs and not willing to abstain during feeding periods

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Controlled Feeding Period

Participants undergo a 2-day run-in of controlled feeding followed by a 7-day feeding period for each of the three feeding periods.

9 days per feeding period

3 visits (in-person) per feeding period

Washout

A 7-day washout period between each feeding period to reset dietary intake.

7 days

Follow-up

Participants are monitored for safety and effectiveness after the feeding trials, with specimen collection for study outcomes and future studies.

4 weeks

Treatment Details

Interventions

• Controlled feeding study of beef and/or pinto beans (Behavioural Intervention)
• Controlled feeding study of eggs and/or black beans (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: 6) Black bean then egg then half black bean and half egg Experimental Treatment 1 Intervention

Group II: 5) Half egg and half black bean, then black bean then egg Experimental Treatment 1 Intervention

Group III: 4) Egg then half Egg and half black bean then black bean Experimental Treatment 1 Intervention

Group IV: 3) Pinto Bean then Beef then half pinto bean and half beef Experimental Treatment 1 Intervention

Group V: 2) Half pinto bean and half beef then pinto bean then beef Experimental Treatment 1 Intervention

Group VI: 1) Beef then half beef and half pinto bean then pinto bean Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Marian Neuhouser

Lead Sponsor

Trials

2

Recruited

60+

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

Collaborator

Trials

2

Recruited

60+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

Michael Dixon

University of Nebraska

Chief Executive Officer since 2010

PhD in Molecular Biology

Dr. Makker

University of Nebraska

Chief Medical Officer since 2020

MD from University of Nebraska Medical School

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

Consuming pinto beans daily for 12 weeks significantly lowered total cholesterol levels by about 8% in healthy adults and 4% in those with premetabolic syndrome, indicating a positive effect on heart health.

While bean consumption increased the production of beneficial short-chain fatty acids (SCFAs) like propionate during in vitro fermentation, it did not show clear benefits for reducing colon cancer risk, as it lowered certain other SCFAs and affected only one bacterial population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pinto bean consumption changes SCFA profiles in fecal fermentations, bacterial populations of the lower bowel, and lipid profiles in blood of humans. Finley, JW., Burrell, JB., Reeves, PG.[2023]

A diet incorporating small red dry beans significantly reduced mammary cancer incidence, multiplicity, and tumor burden in a study involving female Sprague Dawley rats, indicating a potential protective effect against breast cancer.

The mechanism behind this protective effect appears to be the induction of apoptosis in tumor cells, as evidenced by changes in specific protein levels associated with cell death, suggesting that dry beans may play a role in cancer prevention without relying on isoflavones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms associated with dose-dependent inhibition of rat mammary carcinogenesis by dry bean (Phaseolus vulgaris, L.). Thompson, MD., Thompson, HJ., Brick, MA., et al.[2008]

In a randomized crossover trial involving 64 men, a legume-enriched, low-glycemic index diet significantly improved inflammation markers (C-reactive protein and soluble tumor necrosis factor receptors) compared to a high-glycemic American diet.

Both diets led to changes in fasting glucose levels, but only the legume diet showed a favorable trend in reducing inflammation, suggesting that dietary modifications can positively impact insulin resistance and inflammation biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of a legume-enriched, low-glycemic index diet is associated with biomarkers of insulin resistance and inflammation among men at risk for colorectal cancer. Hartman, TJ., Albert, PS., Zhang, Z., et al.[2023]

A study involving 71 low-income men revealed that while most participants were aware of the health benefits of beans, knowledge varied significantly by race, with white men showing greater awareness than black or Hispanic men.

Despite some concerns about digestive issues, a majority of the men enjoyed the taste of beans and consumed them regularly, indicating that enhancing awareness of their health benefits could encourage even greater consumption among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Behaviors, Health, and Bean Nutrition Awareness among Low-Income Men: A Pilot Study. Heer, MM., Winham, DM.[2022]

Cooking common beans significantly reduces antinutritional factors like trypsin inhibitors and tannins, which can improve protein digestibility, although colored beans still contain higher levels of these factors compared to white beans.

To maintain nitrogen balance, adult males require a higher intake of bean protein than previously thought, with recommendations suggesting 0.9-1.0 g/kg/day, and 1.2-1.3 g/kg/day for the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemical composition and evaluation of the protein quality of beans in adult humans by the short-term nitrogen balance method]. Blanco, A., Navarrete, DA., Bressani, R., et al.[2018]

Legume-based complementary foods, particularly common bean and cowpea, are nutritionally superior to traditional corn-soy blend, offering higher protein and dietary fiber, which may help reduce the risk of environmental enteric dysfunction (EED) in children.

The study identified 652 distinct metabolites across the foods, with specific metabolites linked to each legume type, suggesting potential biomarkers for assessing legume intake and its health impacts, while ensuring food safety with no heavy metals detected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nutrient and Metabolite Profile of 3 Complementary Legume Foods with Potential to Improve Gut Health in Rural Malawian Children. Borresen, EC., Zhang, L., Trehan, I., et al.[2021]

In a controlled feeding study with 153 postmenopausal women, serum biomarkers for vitamins and carotenoids were found to effectively reflect dietary intake, showing strong correlations with nutrient consumption.

The study suggests that these serum biomarkers can serve as reliable indicators of nutrient intake, similar to established urinary recovery biomarkers for energy and protein, although further research is needed to assess fatty acid intake measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary biomarker evaluation in a controlled feeding study in women from the Women's Health Initiative cohort. Lampe, JW., Huang, Y., Neuhouser, ML., et al.[2023]

A study involving 14 volunteers demonstrated that urinary excretion of specific biomarkers can effectively indicate the intake of red bell peppers, suggesting a reliable method for assessing dietary consumption.

The analysis revealed significant interindividual variability in biomarker concentrations, but the rapid excretion of certain metabolites indicates that these biomarkers can be used qualitatively to confirm red bell pepper consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Food Intake Biomarkers for Red Bell Peppers in Human Urine Based on HPLC-MS/MS Analysis. Schulz, M., Hübner, F., Humpf, HU.[2023]

This literature review identified promising dietary biomarkers that can accurately reflect the intake of various food groups in the Western diet, which is crucial for epidemiological studies on health and disease.

While many biomarker candidates show moderate to strong correlations with food intake, further research is needed to fully validate their effectiveness, particularly regarding their dose response and reproducibility over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary biomarkers-an update on their validity and applicability in epidemiological studies. Landberg, R., Karra, P., Hoobler, R., et al.[2023]

In a 20-year study of 642 older adults, a dietary biomarker score based on the Mediterranean diet was linked to a lower risk of all-cause and cardiovascular mortality, suggesting its potential as a reliable indicator of health outcomes.

Unlike the biomarker score, the traditional food frequency questionnaire (FFQ) did not show significant associations with mortality, highlighting the added value of using dietary biomarkers for assessing diet quality in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet assessed by a novel dietary biomarker score and mortality in older adults: the InCHIANTI cohort study. Hidalgo-Liberona, N., Meroño, T., Zamora-Ros, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pinto bean consumption changes SCFA profiles in fecal fermentations, bacterial populations of the lower bowel, and lipid profiles in blood of humans. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dry beans inhibit azoxymethane-induced colon carcinogenesis in F344 rats. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Mechanisms associated with dose-dependent inhibition of rat mammary carcinogenesis by dry bean (Phaseolus vulgaris, L.). [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Consumption of a legume-enriched, low-glycemic index diet is associated with biomarkers of insulin resistance and inflammation among men at risk for colorectal cancer. [2023]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Food Behaviors, Health, and Bean Nutrition Awareness among Low-Income Men: A Pilot Study. [2022]

7. Venezuela pubmed.ncbi.nlm.nih.gov

[Chemical composition and evaluation of the protein quality of beans in adult humans by the short-term nitrogen balance method]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The Nutrient and Metabolite Profile of 3 Complementary Legume Foods with Potential to Improve Gut Health in Rural Malawian Children. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary biomarker evaluation in a controlled feeding study in women from the Women's Health Initiative cohort. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of Food Intake Biomarkers for Red Bell Peppers in Human Urine Based on HPLC-MS/MS Analysis. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Dietary biomarkers-an update on their validity and applicability in epidemiological studies. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet assessed by a novel dietary biomarker score and mortality in older adults: the InCHIANTI cohort study. [2022]