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Diet and Systemic Inflammation (DASI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01424306
First Posted: August 26, 2011
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Information provided by (Responsible Party):
Mario Kratz, Fred Hutchinson Cancer Research Center
Results First Submitted: April 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Low-grade Chronic Inflammation
Intestinal Permeability
Type 2 Diabetes Mellitus
Cardiovascular Disease
Obesity
Interventions: Other: Fructose-sweetened beverages
Other: Glucose-sweetened beverages
Other: High-fructose corn syrup-sweetened beverages

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
63 volunteers who responded to newspaper advertisements and fliers posted in the Seattle area were screened for eligibility between December 2011 and December 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of those 63 volunteers screened, 38 did not meet inclusion criteria and 0 declined to participate. 25 subjects randomized

Reporting Groups
  Description
Fructose - Glucose - HFCS

Subjects treated in the order fructose-sweetened beverage - wash out - glucose-sweetened beverage- wash out - HFCS-sweetened beverage

Treatments each lasted 8 days and were separated by a 20-day washout.

Fructose - HFCS - Glucose

Subjects treated in the order fructose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - glucose-sweetened beverage

Treatments each lasted 8 days and were separated by a 20-day washout.

HFCS - Fructose - Glucose

Subjects treated in the order HFCS-sweetened beverage - wash out - fructose-sweetened beverage- wash out - glucose-sweetened beverage

Treatments each lasted 8 days and were separated by a 20-day washout.

HFCS - Glucose - Fructose

Subjects treated in the order HFCS-sweetened beverage - wash out - glucose-sweetened beverage- wash out - fructose-sweetened beverage

Treatments each lasted 8 days and were separated by a 20-day washout.

Glucose - Fructose - HFCS

Subjects treated in the order glucose-sweetened beverage - wash out - fructose-sweetened beverage- wash out - HFCS-sweetened beverage

Treatments each lasted 8 days and were separated by a 20-day washout.

Glucose - HFCS - Fructose

Subjects treated in the order glucose-sweetened beverage - wash out - HFCS-sweetened beverage- wash out - fructose-sweetened beverage

Treatments each lasted 8 days and were separated by a 20-day washout.


Participant Flow:   Overall Study
    Fructose - Glucose - HFCS   Fructose - HFCS - Glucose   HFCS - Fructose - Glucose   HFCS - Glucose - Fructose   Glucose - Fructose - HFCS   Glucose - HFCS - Fructose
STARTED   4   4   3   3   5   6 
COMPLETED   4   4   3   3   4   6 
NOT COMPLETED   0   0   0   0   1   0 
Protocol Violation                0                0                0                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only results of 24 subjects who completed study 'per protocol' are reported here

Reporting Groups
  Description
Study Subjects All six treatment orders combined

Baseline Measures
   Study Subjects 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   9 
Male   15 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   24 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27.4  (4.8) 
Fasting glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 92  (10) 
Physical activity 
[Units: MET-hr/wk]
Mean (Standard Deviation)
 68.7  (45.9) 
Estimated total calorie requirement 
[Units: Kcal/d]
Mean (Standard Deviation)
 2560  (370) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fasting Plasma C-reactive Protein   [ Time Frame: Beginning (day 1) and end (day 9) of each diet period. ]

2.  Primary:   Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period   [ Time Frame: End (day 9) of each diet period ]

3.  Secondary:   Fasting Plasma Adiponectin   [ Time Frame: End (day 9) of each diet period. ]

4.  Secondary:   Mean Daily Calorie Intake   [ Time Frame: The mean daily calorie intake during each of the 8-day diet periods will be calculated. ]

5.  Secondary:   Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test   [ Time Frame: End (day 9) of each diet period. ]

6.  Secondary:   Fasting Plasma Zonulin Concentrations   [ Time Frame: End (day 9) of each diet period. ]

7.  Secondary:   Fasting Plasma Lipopolysaccharide-binding Protein (LBP)   [ Time Frame: End (day 9) of each diet period. ]

8.  Secondary:   Adipose Tissue Inflammation - Tissue Expression of TNF-alpha mRNA   [ Time Frame: End (day 9) of each diet period. ]

9.  Secondary:   Adipose Tissue Inflammation - Tissue Expression of IL-1beta mRNA   [ Time Frame: End (day 9) of each diet period. ]

10.  Secondary:   Adipose Tissue Inflammation - Tissue Expression of IL-6 mRNA   [ Time Frame: End (day 9) of each diet period. ]

11.  Secondary:   Adipose Tissue Inflammation - Tissue Expression of IL-10 mRNA   [ Time Frame: End (day 9) of each diet period. ]

12.  Secondary:   Adipose Tissue Inflammation - Tissue Expression of CCL2 mRNA   [ Time Frame: End (day 9) of each diet period. ]

13.  Secondary:   Adipose Tissue Inflammation - Tissue Expression of IFN-gamma mRNA   [ Time Frame: End (day 9) of each diet period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mario Kratz
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-7362
e-mail: mkratz@fredhutch.org


Publications:

Responsible Party: Mario Kratz, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01424306     History of Changes
Other Study ID Numbers: NHLBI R21 HL108257
R21HL108257 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2011
First Posted: August 26, 2011
Results First Submitted: April 19, 2017
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017