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

NCT ID: NCT01165853

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Insulin Resistance Dyslipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Glucose

Group Type OTHER

Glucose

Intervention Type OTHER

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

Fructose

Group Type OTHER

Fructose

Intervention Type OTHER

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

Interventions

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Glucose

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

Intervention Type OTHER

Fructose

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

Intervention Type OTHER

Other Intervention Names

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sugar sugar

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter J Havel, D.V.M.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Kimber L Stanhope, Ph.D, R.D.

Role: STUDY_DIRECTOR

University of California, Davis

Locations

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Clinical Research Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38969065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21956423 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21613559 (View on PubMed)

Other Identifiers

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R01HL075675

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200412368

Identifier Type: -

Identifier Source: org_study_id

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