115 Participants Needed

Controlled Feeding Diets for Healthy Eating

FM
Overseen ByFrank M Sacks, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Yes, the Controlled Feeding Diet is promising because it can help regulate appetite and food intake, potentially leading to healthier eating habits.1112131415

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

FM

Frank M Sacks, MD

Principal Investigator

Harvard School of Public Health (HSPH)

JS

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

Your body weight is within a healthy range, neither too low nor too high.
Willingness to participate in all study visits

Exclusion Criteria

You have a very high body weight compared to your height.
I have a bleeding disorder that makes blood draws unsafe.
Hypertension- seated blood pressure >140 mmHg or diastolic >90 mmHg
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 days
8 visits (in-person)

Dose Response (DR)

Participants undergo an isocaloric, controlled feeding study examining three dose levels for 10 foods in five pairings over six days each.

18 days
18 visits (in-person)

Follow-up

Participants are monitored for biomarker changes post consumption of test foods.

1 week

Treatment Details

Interventions

  • Dose Response (DR)- Controlled Feeding Diet
  • Pharmacokinetic (PK)- Controlled Feeding Diet
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Harvard School of Public Health (HSPH)

Lead Sponsor

Trials
283
Recruited
17,030,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

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.
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 pilot study involving children aged 8-12 with severe obesity, structured dietary interventions led to significant reductions in BMI, with a median change of -1.2 kg/m2 for individualized menu plans and -1.8 kg/m2 for those receiving both menus and meals.
Both dietary approaches were well-received by families, indicating that structured dietary interventions could be a promising strategy for managing severe pediatric obesity and should be explored further.
Structured Dietary Interventions in the Treatment of Severe Pediatric Obesity: A Pilot Study.Kalarchian, MA., Levine, MD., Marcus, MD.[2021]
In an 8-week controlled-feeding trial involving two diet patterns (Dietary Guidelines for Americans and a typical American diet), both diets were found to be acceptable to participants, with over 95% adherence to the provided foods.
The study highlighted challenges in meeting specific nutrient intake recommendations, particularly for vitamins D and E, dietary fiber, and the sodium-to-potassium ratio, indicating the complexity of designing effective dietary interventions.
Challenges in Designing and Delivering Diets and Assessing Adherence: A Randomized Controlled Trial Evaluating the 2010 Dietary Guidelines for Americans.Krishnan, S., Lee, F., Burnett, DJ., et al.[2022]

References

Dietary biomarker evaluation in a controlled feeding study in women from the Women's Health Initiative cohort. [2023]
Structured Dietary Interventions in the Treatment of Severe Pediatric Obesity: A Pilot Study. [2021]
Challenges in Designing and Delivering Diets and Assessing Adherence: A Randomized Controlled Trial Evaluating the 2010 Dietary Guidelines for Americans. [2022]
The role of structure in dietary approaches for the treatment of pediatric overweight and obesity: A critical review. [2021]
Position of the American Dietetic Association: medical nutrition therapy and pharmacotherapy. [2006]
Advances in assessing ingredient safety. [2017]
Effect of Food on the Pharmacokinetics of Single- and Multiple-Dose Hydrocodone Extended Release in Healthy Subjects. [2018]
Update of US FDA's Total Diet Study food list and diets. [2022]
Joint FAO/WHO Geneva consultation--acute dietary intake methodology. [2007]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety limits for nutrients. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Two effects of high-fat diets on the satiating potency of cholecystokinin-8. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Which foods may be addictive? The roles of processing, fat content, and glycemic load. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Fat in the intestine as a regulator of appetite--role of CCK. [2006]
Why should we study human food intake behaviour? [2019]
Appetite disturbance and the problems of overweight. [2018]
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