The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks

NCT01103921 | Completed DMC

• 3 other identifiers: 200715772R01HL091333R01HL107256
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of consumption of sugar-sweetened beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's sensitivity to insulin.

Conditions

Metabolic Syndrome; Insulin Resistance; Dyslipidemia

Keywords

sugar; fructose; glucose; HFCS; metabolism

Outcome Measures

Primary Outcomes (1)

• 24-hour triglyceride area under the curve

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

  Baseline and 2-week intervention

Secondary Outcomes (1)

• Insulin sensitivity index

  Baseline and 2-week intervention

Study Arms (4)

Glucose

OTHER

Other: Glucose

Fructose

OTHER

Other: Fructose

High-Fructose Corn Syrup

OTHER

Other: High-Fructose Corn Syrup

Aspartame

OTHER

No sugar

Other: No sugar (Aspartame)

Interventions

Glucose OTHER

25% dose at 2-week intervention assigned to subjects.

Also known as: Sugar

Glucose

Fructose OTHER

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

Also known as: Sugar

Fructose

High-Fructose Corn Syrup OTHER

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

Also known as: HFCS

High-Fructose Corn Syrup

No sugar (Aspartame) OTHER

0% dose at 2-week intervention assigned to subjects.

Also known as: Non-caloric sweetener

Aspartame

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index between 18-35
• Self report of stable body weight during the past six months

You may not qualify if:

• Diabetes Mellitus
• Evidence of liver disorder
• Evidence of kidney disorder
• Evidence of thyroid disorder
• Systolic blood pressure consistently over 160mmHg or diastolic blood pressure over 900mmHg
• Triglycerides \> 400mg/dl
• LDL-C \> 240mg/dl
• Hemoglobin \< 8.5 g/dl
• Current, prior (within 2 months), or anticipated use of any hypolipidemic or anti-diabetic agents
• Use of Selective Serotonin Reuptake Inhibitors and anti-hypertensive medications
• Any other condition that, in the opinion of the investigators, would put subject at risk
• Strenuous exerciser
• Pregnant or lactating women
• Smoker

Sponsors & Collaborators

• University of California, Davis: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Clinical Research Center

Sacramento, California, 95655, United States

Location

Related Publications (4)

• Sigala DM, Hieronimus B, Medici V, Lee V, Nunez MV, Bremer AA, Cox CL, Price CA, Benyam Y, Chaudhari AJ, Abdelhafez Y, McGahan JP, Goran MI, Sirlin CB, Pacini G, Tura A, Keim NL, Havel PJ, Stanhope KL. Consuming Sucrose- or HFCS-sweetened Beverages Increases Hepatic Lipid and Decreases Insulin Sensitivity in Adults. J Clin Endocrinol Metab. 2021 Oct 21;106(11):3248-3264. doi: 10.1210/clinem/dgab508.

  PMID: 34265055 DERIVED

• Hieronimus B, Medici V, Bremer AA, Lee V, Nunez MV, Sigala DM, Keim NL, Havel PJ, Stanhope KL. Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults. Metabolism. 2020 Nov;112:154356. doi: 10.1016/j.metabol.2020.154356. Epub 2020 Sep 9.

  PMID: 32916151 DERIVED

• Stanhope KL, Medici V, Bremer AA, Lee V, Lam HD, Nunez MV, Chen GX, Keim NL, Havel PJ. A dose-response study of consuming high-fructose corn syrup-sweetened beverages on lipid/lipoprotein risk factors for cardiovascular disease in young adults. Am J Clin Nutr. 2015 Jun;101(6):1144-54. doi: 10.3945/ajcn.114.100461. Epub 2015 Apr 22.

  PMID: 25904601 DERIVED

• Tryon MS, Stanhope KL, Epel ES, Mason AE, Brown R, Medici V, Havel PJ, Laugero KD. Excessive Sugar Consumption May Be a Difficult Habit to Break: A View From the Brain and Body. J Clin Endocrinol Metab. 2015 Jun;100(6):2239-47. doi: 10.1210/jc.2014-4353. Epub 2015 Apr 16.

  PMID: 25879513 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Dyslipidemias

Interventions

Glucose; Sugars; Fructose; High Fructose Corn Syrup; Aspartame

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Carbohydrates; Ketoses; Dietary Sugars; Dietary Carbohydrates; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter J Havel, D.V.M

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Kimber L Stanhope, Ph.D, R.D.

  University of California, Davis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: October 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)