N/A N=25 Randomized Triple-blind Basic Science

Diet and Systemic Inflammation

Low-grade Chronic Inflammation · Intestinal Permeability · Type 2 Diabetes Mellitus · Cardiovascular Disease · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01424306 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Fasting Plasma C-reactive Protein — 0.91; 1.07; 1.67; 1.09 mg/L — p=0.403

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fructose-sweetened beverages (Other); Glucose-sweetened beverages (Other); High-fructose corn syrup-sweetened beverages (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Fasting Plasma C-reactive Protein	0.91; 1.07; 1.67; 1.09; 1.18; 0.84	0.403
PRIMARY Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period	0.97; 1.14; 0.96	0.933
SECONDARY Fasting Plasma Adiponectin	4635; 4353; 4514	0.196
SECONDARY Mean Daily Calorie Intake	2970; 2940; 2950	0.880
SECONDARY Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test	0.047; 0.043; 0.031	<0.001 sig
SECONDARY Fasting Plasma Zonulin Concentrations	12.78; 12.69; 12.92	0.366
SECONDARY Fasting Plasma Lipopolysaccharide-binding Protein (LBP)	27.7; 26.1; 29.8	0.387
SECONDARY Adipose Tissue Inflammation - Tissue Expression of TNF-alpha mRNA	1.40; 1.44; 1.24	0.476
SECONDARY Adipose Tissue Inflammation - Tissue Expression of IL-1beta mRNA	0.41; 0.33; 0.32	0.596
SECONDARY Adipose Tissue Inflammation - Tissue Expression of IL-6 mRNA	0.53; 0.49; 0.51	0.492
SECONDARY Adipose Tissue Inflammation - Tissue Expression of IL-10 mRNA	0.66; 0.90; 0.95	0.149
SECONDARY Adipose Tissue Inflammation - Tissue Expression of CCL2 mRNA	31.5; 27.2; 25.3	0.056
SECONDARY Adipose Tissue Inflammation - Tissue Expression of IFN-gamma mRNA	0.23; 0.20; 0.23	0.520

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.

Eligibility Criteria

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, 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01424306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.