Controlled Diets for Dietary Biomarker Identification in Healthy Adults

(P1-SDBDC Trial)

Overseen By Marian L. Neuhouser

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marian Neuhouser

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

Disqualifiers: Gastrointestinal disorders, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover better ways to measure dietary intake by identifying dietary biomarkers, indicators found in blood or urine that reveal what someone has been eating. Participants will follow controlled diets featuring either beef and pinto beans or eggs and black beans. Different groups will consume these foods in varied orders to help identify these biomarkers. The trial suits healthy adults with stable weight, no major food allergies or gastrointestinal issues, and a willingness to visit the study center multiple times. As an unphased trial, it offers participants the chance to contribute to groundbreaking research in nutrition science.

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.

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

Research has shown that controlled feeding studies, such as those involving beef and pinto beans or eggs and black beans, are generally safe for healthy adults. These studies analyze blood and urine samples to understand how the body processes different foods. Participants typically follow these specific diets without major issues.

Previous research indicates that similar controlled diet studies have been well-tolerated. Participants consume set amounts of food under close supervision, reducing risks. Foods like beef, beans, and eggs are common in many diets and do not cause significant side effects when eaten in normal amounts.

Although specific data on negative effects from these studies is lacking, the study's focus on understanding dietary effects rather than testing a new drug suggests safety. The use of common foods and established methods supports the belief that these diets are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different controlled diets can help identify dietary biomarkers in healthy adults. Unlike traditional studies that might focus on single nutrients or foods, this trial examines combinations like beef with pinto beans and eggs with black beans. By assessing these varied diets, researchers hope to uncover specific biomarkers that could lead to more personalized nutrition recommendations. This could revolutionize how we understand the impact of diet on health, potentially leading to more tailored dietary guidelines for individuals.

What evidence suggests that this trial's dietary interventions could be effective for identifying dietary biomarkers?

This trial will study controlled diets to identify dietary biomarkers in healthy adults. Participants will be assigned to different treatment arms.

In some arms, participants will consume diets involving beef and pinto beans. Research has shown that pinto beans can improve gut health by supporting beneficial bacteria and boosting the immune system. Additionally, when beef and pinto beans are consumed together, researchers can identify specific markers in the body that accurately reflect dietary intake.

In other arms, participants will consume diets involving eggs and black beans. Studies indicate that eggs provide important nutrients without requiring the replacement of other foods in the diet. Black beans are linked to health benefits such as reducing inflammation and supporting heart health. These foods are being studied to help identify markers that enhance the reporting and evaluation of diets. ^{1 2 3 6 7}

Who Is on the Research Team?

Marian L. Neuhouser

Principal Investigator

Fred Hutchinson Cancer Center

Johanna W. Lampe, PhD, RD

Principal Investigator

Fred Hutchinson Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Controlled feeding study of beef and/or pinto beans
• Controlled feeding study of eggs and/or black beans

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.

How Is the Trial Designed?

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+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

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 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]

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]

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]

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]

In a study involving 53 male F344 rats, those fed a diet of dry beans developed significantly fewer colon tumors compared to those fed a casein diet, indicating that dry beans may have protective effects against colon cancer.

The bean diet not only resulted in fewer rats developing tumors (24% vs. 50% in casein-fed rats) but also showed a lower average number of tumors per rat, suggesting that dry beans contain compounds that inhibit colon carcinogenesis, although the specific components responsible remain unidentified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry beans inhibit azoxymethane-induced colon carcinogenesis in F344 rats. Hughes, JS., Ganthavorn, C., Wilson-Sanders, S.[2018]

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]

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]

In a 28-day dietary intervention trial with 16 adults (7 non-cancer and 9 CRC survivors), the inclusion of 35 grams of cooked navy bean powder in meals was feasible and led to significant increases in fiber intake, particularly for CRC survivors.

Non-cancer participants showed a significant decrease in total caloric intake after four weeks, suggesting that navy bean powder can be a beneficial addition to diets for both cancer prevention and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. Borresen, EC., Gundlach, KA., Wdowik, M., et al.[2021]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-healthy-adults-9-2022-5405c

Controlled Diets for Dietary Biomarker Identification in Healthy ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12242990/

The Dietary Biomarkers Development Consortium Each trial will involve 3 7-d DR feeding periods and 2 PK evaluations and will pair an animal- and plant-based protein food (beef and pinto ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2475299125028951

The Dietary Biomarkers Development Consortium: An ... Each trial will involve 3 7-d DR feeding periods and 2 PK evaluations and will pair an animal- and plant-based protein food (beef and pinto beans; eggs and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10884612/

a 14-d controlled feeding study of weighed food intake - PMC The aim of this study was to evaluate associations between metabolites and weighed food and beverage intake in a controlled feeding study of habitual diet.

5. researchgate.net researchgate.net/publication/346108920_Pinto_beans_modulate_the_gut_microbiome_augment_MHC_II_protein_and_antimicrobial_peptide_gene_expression_in_mice_fed_a_normal_or_western-style_diet

Pinto beans modulate the gut microbiome, augment MHC II ... This study evaluated the effects of pinto beans (PB) supplementation on cecal bacteria, short-chain fatty acids (SCFAs), distal ileal antigen ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05616585

NCT05616585 | Dietary Biomarkers Intervention Core The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose- ...

7. portal.nifa.usda.gov portal.nifa.usda.gov/web/crisprojectpages/1029576-seattle-dietary-biomarker-development-center.html

Seattle Dietary Biomarker Development Center The Seattle Dietary Biomarker Development Center will use two phases of controlled feeding studies for metabolomics discovery of MyPlate foods, food groups and ...