Controlled Feeding Diets for Healthy Eating
Trial Summary
Do I need to stop taking my current medications for the trial?
You may need to stop taking certain medications. Over-the-counter weight-loss aids, anti-inflammatories, and some dietary supplements must be stopped during feeding periods. Prescription medications like diuretics, steroids, NSAIDs, opiates, and others listed in the exclusion criteria may disqualify you from participating. However, some medications like nasal or topical steroids, aspirin, and certain psychiatric drugs are allowed. It's best to discuss your specific medications with the trial staff.
What data supports the idea that Controlled Feeding Diets for Healthy Eating is an effective treatment?
The available research shows that structured dietary interventions, which include controlled feeding diets, are effective in improving weight outcomes, especially in adults. For example, a critical review found that more structured dietary interventions, which control the types and amounts of food consumed, lead to better weight loss results. Additionally, interventions lasting six months or more tend to have better outcomes. This suggests that controlled feeding diets can be an effective treatment for managing weight and improving health.12345
What safety data is available for controlled feeding diets?
The available research does not directly address the safety data for controlled feeding diets specifically. However, it discusses general safety assessment methods for nutrients and food ingredients, such as determining safe intake levels and using various risk assessment methodologies. These methods include traditional 'safe' dose concepts, contemporary approaches like Benchmark Dose (BMD) and Chemical Specific Adjustment Factors (CSAF), and new toxicology research. These approaches can be applied to assess the safety of controlled feeding diets, but specific data on these diets is not provided in the research.678910
Is the Controlled Feeding Diet a promising treatment for healthy eating?
What is the purpose of this trial?
The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies.This research is a two-component pharmacokinetic and pharmacodynamic cross-over dietary feeding trial.* In the PK study, eight foods will be tested, each on a single day, and the design is crossover.* In the DR, the effects of 10 foods will be compared to each other in a randomized, parallel-group design, and the dose-effect of each of the 10 foods will be determined in a randomized, crossover design.
Research Team
Frank M Sacks, MD
Principal Investigator
Harvard School of Public Health (HSPH)
Jonathan S Williams, MD
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pharmacokinetic (PK)
Participants complete a sequence of dietary intakes of up to 8 test foods in a randomized, crossover study. Blood and urine samples are collected for metabolomic analysis.
Dose Response (DR)
Participants undergo an isocaloric, controlled feeding study examining three dose levels for 10 foods in five pairings over six days each.
Follow-up
Participants are monitored for biomarker changes post consumption of test foods.
Treatment Details
Interventions
- Dose Response (DR)- Controlled Feeding Diet
- Pharmacokinetic (PK)- Controlled Feeding Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Harvard School of Public Health (HSPH)
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator