Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Dietary Biomarkers - Dose Response Study

Seeking participants for a month-long controlled feeding research study. This research seeks to increase scientific knowledge of the bodies response to common foods we eat.

Brigham and Women's Hospital Health Screening Nutrition Diets
12 visits
Estimated Time Commitment
Male, Female, 18-years or older
May Be Eligible
Payment up to $1,000, Meals
May Be Offered
Personal health tracking, Survey, Blood draw, Office visit
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

The purpose of this research is to measure and understand the concentrations, fluctuations, and movement of specific foods through the body over time. This study will identify dietary intake biomarkers. In other words, we will study the body’s (absorption, digestion, uptake) responses to individual foods.



Biomarkers can be used to validate how well a person follows a diet. They are an objective measure of what you eat and how much you eat. Biomarkers include vitamins, minerals, fats, calories, and proteins that are found in your blood and urine. 


For more information, visit our study site here: https://www.hsph.harvard.edu/eat-biomarkers/


Why it is important

Biomarkers can be used to validate how well a person follows a diet. They are an objective measure of what you eat and how much you eat. Biomarkers include vitamins, minerals, fats, calories, and proteins that are found in your blood and urine. After eating the test food in controlled amounts, we can then measure how your body breaks down that test food over time. Study findings will provide insight into how biological measures of diet can be used to assess dietary intake in large research studies. It is of great public health importance to discover and develop objective methods of dietary assessment.


What we hope to accomplish

This study will identify dietary intake biomarkers. In other words, we will study the body’s (absorption, digestion, uptake) responses to 10 paired foods at 3 different dose levels (high, medium, zero). The 10 test foods include chicken, beef, salmon, whole wheat bread, oats, potatoes, corn, cheese, soybeans (tofu/tempeh), and yogurt. The body’s response to a pair of test food will be measured over three separate 8 day-controlled feeding periods. During each feeding period a pair of test food will be consumed, as part of a regular diet, in high, medium, and zero amounts. During the feeding periods all meals, snacks, and most beverages are provided by researchers.

Principal Investigator

Jonathan S Williams, MD

Brigham and Women's Hospital

Public Profile

Who can participate

Men and women, 18 years or older, BMI = 18.5-39.9 kg/m2, Willingness to participate and give informed consen, Willing to eat a prescribed diet


Healthy Volunteers

Healthy volunteers are eligible for this study

Who cannot participate


  • Body mass index greater than or equal to 40 kg/m2

  • Hypertension- seated blood pressure >140 mmHg or diastolic >90 mmHg

  • Use of illicit drugs and not willing abstain during feeding periods.

  • Women who are pregnant or lactating

  • Cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment. Except for non-melanoma skin cancer.

  • Previous gastrointestinal resection or gastric bypass surgery

  • Food allergies/intolerances or major dislikes to foods used in the study menus; unwilling to consume study foods.

  • Inability to freely give informed consent

  • Unwilling to stop taking OTC dietary supplements that interfere with the test foods being studied, including pills, chewables, liquids or powders for the following: protein supplements, soy, fiber, flaxseed, fish oil (incl. cod liver oil), probiotics, carotenoids, selenium, other antioxidants, other phytochemicals, glucosamine and chondroitin. If vitamin supplement is MD prescribed, the participant may be enrolled subject to the investigator’s judgment. Staff will review supplement to determine eligibility. 


* Additional exclusion criteria and more detail will be reviewed at screening

What you may be asked to do


  • Attend an in-person screening visit

  • Eat controlled meals and snacks for 3 separate 9 day feeding periods. ( 2 days of a Run-in diet and 6 days assigned test food pairing)

  • Collect 6 stool samples at home

  • Attend 3 in-person clinic visits (221 Longwood Ave, Boston) for blood and urine collection.

  • Attend up to 12 in-person food pick up visits (75 Francis St, Boston) to pick up controlled meals and snacks.


 


Screening:



  • You will complete physical measurements such as height and weight and your blood pressure will be measured.

  • You will answer questionnaires about your activity, medical history, and diet.

  • You will complete a screening blood draw for eligibility about 20 ml or 1 Tablespoon.


If Eligible;



  • Complete a 2-day-run-in (preparation diet) where all meals and snacks are provided for a total of 6 regular meals

  • Complete 6 days of controlled meals and snacks which include the assigned test food pair.

  • You will eat the prescribed diet of the test food at three dose levels (high, medium, zero) All meals and snacks are provided.

  • The test food you will eat, will be one of the following pairings: beef/whole wheat bread; chicken/potato; salmon/corn; cheese/soy; yogurt/oats.

  • You will eat the prescribed diet of the test food at three dose levels (high, medium, zero) All meals and snacks are provided. 



  • You will come into the Brigham and Women’s Hospital-Clinical Center of Investigation (BWH-CCI) to pick up meals and to complete specimen collections of blood, urine.

  • You will complete 3 blood draws during the study. Each blood draw is 6ml or about 1.5 teaspoon. 

  • You will provide a stool sample at the beginning and end of each feeding period for a study total of 6 stool samples 

  • You will provide 3  overnight urine sample at the end of each feeding period


The total duration of your participation is about one month or the time it takes to complete all 3 (8 day) test food dose levels. *Dose levels do not need to be completed consecutively.


Project activities may include:

  • Personal health tracking
  • Survey
  • Blood draw
  • Office visit

Estimated Time Commitment

12 visits

What You May Get

We cannot promise any benefits to you or others from your taking part in this research. Possible benefits may include the provided study meals. However, half of the meals provided will consist of a single study test food. The potential benefits to society may be large. Study findings will help us discover and develop objective methods of dietary assessments.


Compensation is as follows: 


If you complete all three feeding periods you will receive $1000.
• Run-In/ Preparation Diet= no compensation
• $100 for Feeding Period 1
• $300 for Feeding Period 2
• $600 for Feeding Period 3
Total Compensation Possible= $1000

Location

Ambulatory Clinic Center (ACC)
221 Longwood Avenue Boston, MA 02115 AND Food Pick Up at 75 Francis Street, Boston

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Travel

  • Accessible by public transportation
  • Parking available
  • Parking reimbursed

Travel and Parking Details

You will receive parking validation for visits that involve study measurements at Mass General Brigham locations.

Additional Information

Project Website

https://www.hsph.harvard.edu/eat-biomarkers/


Participating Institutions


Funding Source

  • NIH or Other Federal
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