What side effects are associated with this type of intervention?

Common treatments for healthy adults involving dietary interventions, such as those studied in controlled feeding studies, generally focus on altering macronutrient composition (e.g., low-fat, low-carbohydrate, Mediterranean diets) and monitoring dietary intake through biomarkers. Known side effects of these dietary interventions can include gastrointestinal discomfort, changes in bowel habits, and nutrient deficiencies if not properly balanced. For example, low-carbohydrate diets may lead to constipation and electrolyte imbalances, while low-fat diets might result in deficiencies in fat-soluble vitamins. It is important for individuals to consult with healthcare providers to ensure dietary changes are safe and nutritionally adequate.

What prior FDA approvals exist?

The FDA has approved various dietary supplements and nutritional interventions aimed at improving overall health in adults. These include vitamins, minerals, and other dietary supplements that support general well-being and prevent nutritional deficiencies. While specific FDA approvals for treatments directly related to dietary biomarkers and metabolomics are not detailed, the agency has a history of approving supplements like folic acid, vitamin B12, and omega-3 fatty acids, which are often studied for their health benefits and potential roles in disease prevention.

What other types of research exist?

Promising novel alternatives to controlled feeding studies for the identification and validation of dietary biomarkers through metabolomics assays include: 1) Remote dietary monitoring using digital food diaries and mobile applications that utilize image recognition and AI to accurately track food intake. 2) Wearable biosensors that continuously monitor physiological responses and metabolite levels in real-time. 3) Advanced non-invasive sampling techniques such as saliva or breath analysis for metabolomic profiling. 4) Integration of machine learning algorithms with large-scale dietary and health data to predict dietary intake and its metabolic effects. These methods can provide more practical and scalable solutions for dietary assessment and biomarker validation in healthy adults.

← Back to Search

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for healthy adults often involve dietary interventions that aim to optimize metabolic health and reduce inflammation. For example, low-glycemic load diets can help regulate blood sugar levels and improve energy metabolism by minimizing rapid spikes in glucose and insulin. Similarly, diets rich in omega-3 fatty acids from fish oil have been shown to reduce inflammation by modulating the production of pro-inflammatory cytokines. These dietary patterns are important for healthy adults as they can prevent the onset of chronic diseases such as diabetes, cardiovascular disease, and obesity. Controlled feeding studies using metabolomics assays help identify specific biomarkers that can validate the effectiveness of these dietary interventions, providing a scientific basis for personalized nutrition recommendations.

Plasma metabolomics profiles suggest beneficial effects of a low-glycemic load dietary pattern on inflammation and energy metabolism.