Diet and Metabolic Inflammation

NCT02539355 | Completed

• 2 other identifiers: NCI2P30CA015704CCSG Y39 Pilot: Kratz, M
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Insulin Resistance; Diabetes; Cancer; Obesity; Inflammation

Keywords

Insulin resistance; Diabetes; Cancer; Obesity; Inflammation

Outcome Measures

Primary Outcomes (2)

• Change in adipose tissue macrophage cell surface expression of metabolic activation marker CD36 as measured by relative mean fluorescence intensity

  As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages

  Change between beginning (day 1) and end (week 12) of the study diet period.

• Change in adipose tissue macrophage cell surface expression of metabolic activation marker ABCA1 as measured by relative mean fluorescence intensity (rMFI)

  As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages

  Change between beginning (day 1) and end (week 12) of the study diet period.

Secondary Outcomes (9)

• Change in adipose tissue expression of the key pro-inflammatory cytokine, tumor necrosis factor α (TNFα) assessed by qPCR

  Change between beginning (day 1) and end (week 12) of the study diet period.

• Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-6 (IL-6) assessed by qPCR

  Change between beginning (day 1) and end (week 12) of the study diet period.

• Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-1 beta (IL-1beta) assessed by qPCR

  Change between beginning (day 1) and end (week 12) of the study diet period.

• Change in adipose tissue expression of the key anti-inflammatory adipokine, adiponectin assessed by qPCR

  Change between beginning (day 1) and end (week 12) of the study diet period.

• Change in systemic insulin sensitivity assessed by the Matsuda-DeFronzo Insulin Sensitivity Index

  Change between beginning (day 1) and end (week 12) of the study diet period.

Other Outcomes (2)

• Dietary adherence to prescribed 12-week diet assessed by dietary compliance score

  Assessed at the end of the study (week 12).

• Changes in gut microbiota assessed by stool sample analysis

  Change between beginning (day 1) and end (week 12) of the study diet period.

Study Arms (2)

Diet A

ACTIVE COMPARATOR

Standard Healthy Diet (Diet A)

Other: Diet A

Diet B

EXPERIMENTAL

Alternative Test Diet (Diet B)

Other: Diet B

Interventions

Diet A OTHER

12-week diet

Diet A

Diet B OTHER

12-week Diet

Diet B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus; Neoplasms; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Mario Kratz, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Member

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 3, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 24, 2016

Record last verified: 2016-10

Locations

US (1)