Clinical trial · Interventional
Diet and Metabolic Inflammation
NCT02539355CI-TRIAL-00024403completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Obesity is a risk factor for several common cancers, including those of the breast, colon, liver, and pancreas. Proposed molecular links between obesity and these types of cancer include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic inflammatory processes in expanded adipose tissue. The objective of this proposal is to test the hypothesis that adipose tissue inflammation can be reduced by the foods we eat.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet A | Other | — | UNRESOLVED |
| Diet B | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Diet A
- description
- Standard Healthy Diet (Diet A)
- interventionNames
- Other: Diet A
- type
- EXPERIMENTAL
- label
- Diet B
- description
- Alternative Test Diet (Diet B)
- interventionNames
- Other: Diet B
Primary outcomes (2)
- measure
- Change in adipose tissue macrophage cell surface expression of metabolic activation marker CD36 as measured by relative mean fluorescence intensity
- timeFrame
- Change between beginning (day 1) and end (week 12) of the study diet period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Body Mass Index (BMI) ≥ 28 kg/m2 * Homeostasis model assessment insulin resistance (HOMA-IR) index \> 2.0 * Body weight within 10% of weight 3 months before starting the study * Able to come to the FHCRC Prevention Center for one 1-hour pre-study visit and two clinic visits of \~4.5 hours duration each * Able and willing to attend bi-weekly dietary group counseling sessions at FHCRC during the 12-week intervention period * Willingness and ability to follow the dietary regimen * Able to complete repeated 3-day food records before and during the dietary intervention. * Willingness to maintain usual lifestyle habits (other than diet) throughout the study (e.g., physical activity habits) * Ability to understand, speak, and write in English * Ability to provide informed written consent Exclusion Criteria: * Any previous or current use of antidiabetic medications or insulin * Presence or history of major chronic inflammatory or autoimmune disease (e.g., lupus, rheumatoid arthritis, Hashimoto's thyroiditis, inflammatory bowel disease, celiac disease, multiple sclerosis), malabsorption syndromes, or diseases of the liver, thyroid, or kidneys (stage IV or later chronic kidney disease) * Food allergies or intolerances against major study foods * Intake of drugs likely to interfere with study endpoints, including corticosteroids and anabolic steroids, hormone replacement therapy, NSAIDS (more than 3 times per week and/ or more than 600 mg per day), warfarin (within 3 months of starting the study), antibiotics or probiotics (within 2 weeks of starting the study) * Presence or recent history of anemia (within 3 months of starting the study) * Participation in another study that includes an intervention of any kind or a blood draw \>300 mL over 3 months * Alcohol intake \> 2 drinks per day * Use of tobacco products, eCigarettes, or recreational drugs on more than 2 days per month * Current or recent (within 12 months of starting the study) pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.