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Controlled Feeding Diets for Healthy Eating
N/A
Recruiting
Led By Jonathan S Williams, MD
Research Sponsored by Harvard School of Public Health (HSPH)
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 pharmacokinetic phase 1 [ time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hours post consumption of the test food.] dose response phase 2: [time frame: day 0 and day 7 post consumption of 6 days-controlled feeding of paired test foods.
Awards & highlights
Study Summary
This trial will test how 8-10 foods interact with one another and how the dose affects the outcome.
Who is the study for?
This trial is for healthy adults over 18 with a BMI of 18.5-39.9 kg/m2 who are willing to attend all study visits. It's not suitable for those with certain gastrointestinal conditions, recent severe heart issues, active cancer treatments, significant weight changes recently, high blood pressure, or specific dietary restrictions and medication use.Check my eligibility
What is being tested?
The trial is testing how the body processes eight different foods in a crossover design (each participant tries each food) and compares the effects of ten foods in both parallel-group and crossover designs to understand dose-response relationships.See study design
What are the potential side effects?
Since this is a nutritional study focusing on controlled diets rather than drug interventions, side effects may be minimal but could include digestive discomfort or allergic reactions if participants have unknown food sensitivities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pharmacokinetic phase 1 [ time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hours post consumption of the test food.] dose response phase 2: [time frame: day 0 and day 7 post consumption of 6 days-controlled feeding of paired test foods.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pharmacokinetic phase 1 [ time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hours post consumption of the test food.] dose response phase 2: [time frame: day 0 and day 7 post consumption of 6 days-controlled feeding of paired test foods.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serum/plasma biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Stool biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Trial Design
2Treatment groups
Experimental Treatment
Group I: PharmacokineticExperimental Treatment1 Intervention
Single Day Intervention of 10 test foods
Group II: Dose ResponseExperimental Treatment1 Intervention
Six day, 3 level (zero, medium, high dose) controlled feeding study
Find a Location
Who is running the clinical trial?
Harvard School of Public Health (HSPH)Lead Sponsor
272 Previous Clinical Trials
16,304,910 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,477 Total Patients Enrolled
2 Trials studying Healthy Eating
1,183 Patients Enrolled for Healthy Eating
Jonathan S Williams, MDPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very high body weight compared to your height.Your body weight is within a healthy range, neither too low nor too high.I have a bleeding disorder that makes blood draws unsafe.I am an adult over 18 and in good health.Your weight has changed by more than 5% in the past 3 months.I am unable to understand and agree to the study on my own.You use illegal drugs and are not willing to stop using them during the study.I have not taken any antibiotics in the last 3 months.I have had surgery on my digestive system.I am not pregnant or breastfeeding.I have been hospitalized for heart disease or related conditions in the last 6 months and my condition is not stable.I am currently undergoing or recently completed radiation or chemotherapy for cancer, excluding non-melanoma skin cancer.You drink more than 2 alcoholic drinks per day and are not willing to stop drinking during the study.My lab tests are not within the normal range and I am taking certain prescription medications.I am willing to stop taking certain supplements that may affect the study.I have a history of certain gastrointestinal conditions.I regularly use over-the-counter weight-loss or anti-inflammatory products and am unwilling to stop.You are currently using tobacco, marijuana, hookahs, vape, or e-cigarettes and are not willing to stop using them during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmacokinetic
- Group 2: Dose Response
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open opportunities to join this experiment?
"Per the records on clinicaltrials.gov, this study is actively seeking participants as of today's date. This trial was first unveiled to the public on February 1st 2023 and has been updated since then."
Answered by AI
How many participants is the medical trial recruiting at this time?
"Affirmative. According to the information found on clinicaltrials.gov, enrollment is still open for this medical trial that was first posted on February 1st 2023 and subsequently edited a month later. 115 patients need to be recruited from one research centre in order for the study to reach completion."
Answered by AI
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