ClinicalTrials.gg
CompletedNCT01165853IPOPUpdated May 30, 2017

Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks

An interventional study of Glucose and Fructose in Metabolic Syndrome, Insulin Resistance and Dyslipidemia, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 40 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
40 Years to 72 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolic Syndrome
  • Insulin Resistance
  • Dyslipidemia
03

In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 145 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Other
    Glucose

    Other: Glucose

  • Other
    Fructose

    Other: Fructose

Interventions

  • OtherGlucose

    25% dose at 8-week intervention assigned to subjects.

    Also known as: sugar

  • OtherFructose

    25% dose at 8-week intervention assigned to subjects.

    Also known as: sugar

06

What researchers measure

Primary outcomes

  1. 24-hour triglyceride area under the curve

    32 serial blood samples are collected over a 24 hour period.

    Time frame: Baseline and 8-week intervention

Secondary outcomes

  1. Insulin sensitivity index

    Insulin sensitivity is assessed using the deuterated glucose disposal method.

    Time frame: Baseline and 8-week intervention

07

Study locations

1 site
  • Clinical Research Center
    Sacramento, California 95655, United States
08

References and documents

Publications

  • Law HG, Stanhope KL, Zhang W, Myagmarsuren M, Jamshed ZM, Khan MA, Bang H, Havel PJ, Berglund L, Enkhmaa B. Lipoprotein(a) and diet: consuming sugar-sweetened beverages lowers lipoprotein(a) levels in obese and overweight adults. J Lipid Res. 2024 Aug;65(8):100588. doi: 10.1016/j.jlr.2024.100588. Epub 2024 Jul 4. PubMed 38969065 ↗
  • 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. PubMed 21956423 ↗
  • 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. PubMed 21613559 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01165853
Responsible party
Sponsor
First posted
Jul 20, 2010
Start date
Jul 2005
Primary completion
Nov 2007
Completion
Jul 2012
Last update
May 30, 2017

Study contacts

Peter J Havel, D.V.M.
principal investigator · University of California, Davis
Kimber L Stanhope, Ph.D, R.D.
study director · University of California, Davis

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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