Diet and Systemic Inflammation
DASI
2 other identifiers
interventional
25
1 country
1
Brief Summary
People with chronic low-grade inflammation have a higher risk for certain diseases such as cardiovascular disease or type 2 diabetes. While it is known that obese people are more likely to show signs of low-grade inflammation than lean individuals, it is unclear what causes this inflammation. In the proposed study, the investigators will examine whether the sugar fructose, when consumed in a sweetened beverage, triggers low-grade inflammation in healthy men and women compared with other caloric sweeteners.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
August 14, 2017
CompletedAugust 14, 2017
July 1, 2017
2.5 years
August 24, 2011
April 19, 2017
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fasting Plasma C-reactive Protein
The concentration of C-reactive protein in fasting plasma will be measured by high-sensitivity assay at the beginning (day 1) and end (day 9) of each 8-day dietary period.
Beginning (day 1) and end (day 9) of each diet period.
Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period
The concentration of interleukin-6 in fasting plasma will be measured by high-sensitivity enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.
End (day 9) of each diet period
Secondary Outcomes (11)
Fasting Plasma Adiponectin
End (day 9) of each diet period.
Mean Daily Calorie Intake
The mean daily calorie intake during each of the 8-day diet periods will be calculated.
Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test
End (day 9) of each diet period.
Fasting Plasma Zonulin Concentrations
End (day 9) of each diet period.
Fasting Plasma Lipopolysaccharide-binding Protein (LBP)
End (day 9) of each diet period.
- +6 more secondary outcomes
Study Arms (3)
Fructose-sweetened beverages
EXPERIMENTALIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a fructose-sweetened beverage for 8 days.
Glucose-sweetened beverages
EXPERIMENTALIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a glucose-sweetened beverage for 8 days.
High-fructose corn syrup-sweetened beverages
EXPERIMENTALIn addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a high-fructose corn syrup-sweetened beverage for 8 days.
Interventions
In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a fructose-sweetened beverage for 8 days. The amount of fructose consumed will be 25% of the subject's estimated daily calorie requirement.
In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a glucose-sweetened beverage for 8 days. The amount of glucose consumed will be 25% of the subject's estimated daily calorie requirement.
In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a high-fructose corn syrup-sweetened beverage for 8 days. The amount of high-fructose corn syrup consumed will be 25% of the subject's estimated daily calorie requirement.
Eligibility Criteria
You may qualify if:
- Age: 18-65 years;
- BMI 20-40 kg/m2;
- Weight stable to within 10 pounds for 6 months prior to entering the study, and at their lifetime maximum weight (or within 30 pounds of it; excluding pregnancy);
- Ability to be admitted for \~30 minutes on three occasions, and \~6 hours on three occasions to the FHCRC Prevention Center;
- Ability to provide informed written consent;
- Willingness to consume only food and beverages provided by the Human Nutrition Laboratory of the FHCRC Prevention Center for three periods of 8 days each.
You may not qualify if:
- Presence or history of chronic inflammatory, autoimmune or metabolic diseases;
- Presence of phenylketonuria, hereditary fructose intolerance, fructose malabsorption, or malabsorption syndromes;
- Abuse of alcohol (\>2 drinks per day), smoking, or use of recreational drugs;
- Current or recent (within three months) intake of medications likely to interfere with study endpoints (insulin, antidiabetics, β-blockers, anabolic steroids, glucocorticosteroids, daily high-dose non-steroidal anti-inflammatory drugs, warfarin, antibiotics, probiotics);
- Presence of anemia, recent (within 2 months) history of anemia;
- Anyone not willing or able to eat the provided food;
- Current or recent (within 12 months) pregnancy or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Washingtoncollaborator
Study Sites (1)
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (2)
Kuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Callahan HS, Weigle DS, Kratz M. No difference in ad libitum energy intake in healthy men and women consuming beverages sweetened with fructose, glucose, or high-fructose corn syrup: a randomized trial. Am J Clin Nutr. 2015 Dec;102(6):1373-80. doi: 10.3945/ajcn.115.116368. Epub 2015 Nov 4.
PMID: 26537945BACKGROUNDKuzma JN, Cromer G, Hagman DK, Breymeyer KL, Roth CL, Foster-Schubert KE, Holte SE, Weigle DS, Kratz M. No differential effect of beverages sweetened with fructose, high-fructose corn syrup, or glucose on systemic or adipose tissue inflammation in normal-weight to obese adults: a randomized controlled trial. Am J Clin Nutr. 2016 Aug;104(2):306-14. doi: 10.3945/ajcn.115.129650. Epub 2016 Jun 29.
PMID: 27357093BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mario Kratz
- Organization
- Fred Hutchinson Cancer Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Kratz, MS, PhD
Fred Hutchinson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Member
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 26, 2011
Study Start
October 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 14, 2017
Results First Posted
August 14, 2017
Record last verified: 2017-07