Obesity Clinical Trial
— DASIOfficial title:
Diet and Systemic Inflammation
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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, ß-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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Heart, Lung, and Blood Institute (NHLBI), University of Washington |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Primary | Fasting plasma interleukin-6 | The concentration of interleukin-6 in fasting plasma will be measured by high-sensitivity enzyme-linked immunosorbent 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. | No |
Secondary | Fasting plasma total and high-molecular weight adiponectin | The concentration of total and high-molecular weight adiponectin in fasting plasma will be measured by enzyme-linked immunosorbent 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. | No |
Secondary | Mean daily calorie intake | Mean daily calorie intake will be assessed during each of the three 8-day diet periods. All foods will be provided to the subjects in excess of what they are estimated to require, and calorie intake will be assessed by subtracting returned foods from foods administered. | The mean daily calorie intake during each of the 8-day diet periods will be calculated. | No |
Secondary | Intestinal permeability, as assessed by the 5-hour urinary lactulose/mannitol test | Intestinal permeability will be assessed on day 9 of each diet period by administering a beverage containing 2 g of mannitol and 5 g of lactulose followed by collecting urine for 5 hours afterwards. Recovery of mannitol and lactulose in urine will be measured by gas chromatography, and will be indicative of the degree of intestinal permeability. | At the end (day 9) of each diet period. | No |
Secondary | Fasting plasma zonulin concentrations | Zonulin concentrations will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. Plasma zonulin is a marker of intestinal permeability. | At the end (day 9) of each diet period. | No |
Secondary | Fasting plasma lipopolysaccharide-binding protein (LBP) | Lipopolysaccharide-binding protein (LBP) will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. LBP is an acute phase protein secreted by the liver in response to endotoxin (lipopolysaccharide) exposure. | At the end (day 9) of each diet period. | No |
Secondary | Adipose tissue inflammation | A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by (a) flow cytometric characterization of adipose tissue leukocytes, and (b) whole adipose tissue gene expression analysis. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period. | At the end (day 9) of each diet period. | No |
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