Diet and Metabolic Inflammation

Completed · Not applicable

Conditions studied: Insulin Resistance, Diabetes, Cancer, Obesity, Inflammation

In brief

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.

Key facts

Study ID

NCT02539355

Run by

Fred Hutchinson Cancer Center

People needed

16

Starts

2015-08-01

Expected to finish

2016-09-01

Last updated by the study team

2016-10-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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