Clinical trial NCT01165853: Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks
Official title: Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks on Hormones and Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Insulin Resistance
Dyslipidemia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-07-20
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is compare the effects of consuming glucose- and fructose-sweetened beverages on appetite, body weight, body fat, and the amount of energy the body burns as well as effects on blood pressure, hormones, blood triglycerides and cholesterol, and the body's sensitivity to the insulin.

Detailed description: The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or glucose-sweetened beverages (25% of energy) with meals. Experimental procedures, including 24-hour serial blood sampling, 26-h stable isotoped infusions, post-heparin blood collection, gluteal biopsies, metabolic rate monitoring, computed tomography scans of the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 10-week intervention period at the UC Davis School of Medicine/Sacramento Veterans Affairs Medical Center Clinical Research Center (CCRC). During the 2-week inpatient baseline period, subjects are served energy balanced diets containing 15% of energy as protein, 30% as fat, and 55% as complex carbohydrate. Following the baseline period, the subjects reside at home for 8 weeks and consume their usual ad libitum diet along with 25% of energy requirements as fructose- or glucose-sweetened beverages. Subjects then return to the CCRC for the 2-week inpatient intervention period at the end of the study and are served energy-balanced diets containing 15% of energy as protein, 30% as fat, 30% as complex carbohydrate and 25% of energy as fructose- or glucose-sweetened beverage.

Eligibility criteria: Inclusion Criteria:

* Self-report of stable body weight
* Women were post-menopausal based on a self-report of no menstruation for at least one year

Exclusion Criteria:

* evidence of diabetes
* renal or hepatic disease
* fasting serum TG concentrations \>400 mg/dl
* hypertension (\>140/90 mg Hg)
* surgery for weight loss
* individuals who smoked
* reported exercise of more than 3.5 hours/week at a level more vigorous than walking
* having used thyroid, lipid-lowering, glucose-lowering, anti-hypertensive, anti-depressant, or weight loss medications
* habitual ingestion of more than one sugar-sweetened beverage/day or more than two alcoholic beverages/day

Primary outcomes:
measure: 24-hour triglyceride area under the curve
timeFrame: Baseline and 8-week intervention
Secondary outcomes:
measure: Insulin sensitivity index
timeFrame: Baseline and 8-week intervention
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Clinical Research Center
state: California
Study officials:
affiliation: University of California, Davis
name: Peter J Havel, D.V.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Kimber L Stanhope, Ph.D, R.D.
role: STUDY_DIRECTOR
References:
citation: Cox CL, Stanhope KL, Schwarz JM, Graham JL, Hatcher B, Griffen SC, Bremer AA, Berglund L, McGahan JP, Keim NL, Havel PJ. Circulating concentrations of monocyte chemoattractant protein-1, plasminogen activator inhibitor-1, and soluble leukocyte adhesion molecule-1 in overweight/obese men and women consuming fructose- or glucose-sweetened beverages for 10 weeks. J Clin Endocrinol Metab. 2011 Dec;96(12):E2034-8. doi: 10.1210/jc.2011-1050. Epub 2011 Sep 28.
citation: Stanhope KL, Griffen SC, Bremer AA, Vink RG, Schaefer EJ, Nakajima K, Schwarz JM, Beysen C, Berglund L, Keim NL, Havel PJ. Metabolic responses to prolonged consumption of glucose- and fructose-sweetened beverages are not associated with postprandial or 24-h glucose and insulin excursions. Am J Clin Nutr. 2011 Jul;94(1):112-9. doi: 10.3945/ajcn.110.002246. Epub 2011 May 25.