Diet Modification for Obesity
(INTERACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how genetics and diet affect obesity, with a focus on brain inflammation. Researchers examine identical twins with different eating habits to determine if these habits cause changes in body fat and brain inflammation. The trial includes two studies: one compares twins with different diets, and the other assigns a specific diet for two weeks. Identical twins with different eating habits who are part of the Washington State Twin Registry may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on the influence of diet and genetics on obesity.
Do I have to stop taking my current medications for the trial?
You will need to stop taking any weight-loss medications or other medications known to alter appetite to participate in this trial.
What prior data suggests that this diet modification is safe?
Previous studies have generally found dietary changes to be safe and manageable. Research has shown that following a diet of 1000 to 1500 calories a day can promote weight loss without serious side effects. Some individuals might experience hunger or low energy, but these feelings are typically mild and temporary.
One study examined lifestyle changes, including diet, and found that altering eating habits helped manage weight and reduce the risk of conditions like heart disease. Although these changes can be challenging, they are generally safe. Serious problems are rare, indicating that dietary changes are a well-tolerated method for addressing obesity.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how diet modification can uniquely affect obesity by examining monozygotic twins with different habitual diets. Unlike standard treatments that often focus on medication or surgery, this approach investigates the impact of controlled dietary changes on body composition, liver fat, and brain inflammation. By studying twins, researchers aim to isolate the effects of diet from genetic factors, potentially offering new insights into personalized nutrition strategies for managing obesity.
What evidence suggests that diet modification might be an effective treatment for obesity?
This trial will explore the effects of diet modification on obesity through two different study designs. Research has shown that dietary changes can aid weight loss and improve health. One study found that participants following a diet plan lost an average of 3.2 kg over a year, while those who did not change their diet lost only 0.7 kg. Another study demonstrated that losing just 5% of body weight can reduce the risk of health issues like type 2 diabetes. For children, special diets proved more effective in reducing BMI (a measure of body fat based on height and weight) than standard care. Overall, dietary changes are a proven method to manage obesity and enhance health.16789
Who Is on the Research Team?
Ellen Schur, MD, MS
Principal Investigator
University of Washington
Are You a Good Fit for This Trial?
This trial is for adults aged 20-45 who are twins in the Washington State Twin Registry and have different eating habits from their co-twin. Participants must be able to follow special diets, not have major health issues or severe food restrictions, and both twins must agree to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Study 1
Monozygotic twin pairs with differential habitual diet practices undergo measurements including body composition, and MRI measures of hepatic adiposity and neuroinflammation
Study 2
Monozygotic twin pairs are provided an assigned diet for 14 days with 3 in-person study visits including brain MRI, body composition measurements, blood draws, and questionnaires
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Diet modification
Trial Overview
The study looks at how genetics and diet affect body weight and brain inflammation by having twins follow specific diets—one high-calorie week and one low-calorie week—and measuring changes in their bodies and brains.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Monozygotic twin pairs will be provided an assigned diet for 14-days.
Monozygotic twin pairs with differential habitual diet practices will undergo measurements including body composition, and MRI measures of hepatic adiposity and neuroinflammation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Dietary interventions for obesity: clinical and mechanistic ...
Mean 1-year weight loss from a subsample of participants was 3.2 kg (–3.7%) in the intervention group versus 0.7 kg (–0.8%) in control participants (95% CI = – ...
a retrospective chart review at a Center of Excellence in UAE
A modest weight loss of ≥5 % among patients with obesity is associated with a reduced risk of type 2 diabetes, hypertension, and other obesity-related ...
Effectiveness of dietary interventions on weight outcomes in ...
The results revealed that children who received dietary interventions had greater reduction in BMI when compared with usual healthcare (WMD: –0.12; 95% CI: – ...
Evaluation of the effectiveness of a restricted diet therapy ...
By month 12, all participants in the intervention group achieved ≥5 % weight loss, with 59.18 % achieving ≥10 %, compared to 38.00 % and 6.00 % in the control ...
A Dietary Intervention in Adults with Overweight or Obesity ...
found that both low-carbohydrate and low-fat diets produced similar weight loss results over a standard 6-month period, but the effect diminished by 12 months, ...
Successful dietary changes correlate with weight‐loss ... - PMC
A large divergence in weight loss among participants was observed; successful (n = 9) achieved −12.9(9.6)% while unsuccessful achieved −2.03(2.78)%. Dietary ...
Weight loss and risk reduction of obesity-related outcomes ...
In this study, we estimated how the risks of ten obesity-related outcomes change in response to weight loss of 13%. The greatest benefits of ...
A systematic review of effects, potentialities, and limitations ...
Most trials presented better weight loss results with the association of calorie restrictions and theory-based interventions delivered by dietitians or ...
Lifestyle Modification Approaches for the Treatment of Obesity ...
This article reviews the principal components of comprehensive lifestyle modification, which include diet, physical activity, and behavior therapy.
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