Adverse Metabolic Effects of Dietary Sugar

NCT02548767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-09-16

No results posted yet for this study

Summary

It is not known whether consumption of excessive amounts of sugar can increase risk factors for cardiovascular disease or diabetes in the absence of increased food (caloric) intake and weight gain, nor whether the negative effects of sugar consumption are made worse when accompanied by weight gain. This study will investigate the effects of excess sugar when consumed with an energy-balanced diet that prevents weight gain, and the effects of excess sugar when consumed with a diet that can cause weight gain. The results will determine whether excess sugar consumption and excess caloric intake that lead to weight gain have independent and additive effects on risk factors for cardiovascular disease or diabetes, and will have the potential to influence dietary guidelines and public health policy.

Conditions

Interventions

OTHER

high fructose corn syrup

High fructose corn syrup provided as 15% HFCS/85% water (weight/weight) fruit-flavored beverage

OTHER

aspartame

Aspartame provided as 0.04% aspartame/99.96% water (weight/weight), fruit-flavored beverage

OTHER

Energy-balanced diet

Provided in quantities that equal energy requirement. Formulated such that the overall macronutrient intake; including beverage; equal 45%/5% energy requirement at complex/simple carbohydrate, 35% energy requirement as fat, 15% energy requirement as protein.

OTHER

Ad libitum diet

Provided in quantities that exceed energy requirement by approximately 25%. Formulated such that the overall macronutrient intake; including beverage; equals approximately 45%/5% energy requirement at complex/simple carbohydrate, 35% energy requirement as fat, 15% energy requirement as protein.

Sponsors & Collaborators

  • Touro University, California

    collaborator OTHER
  • University of Southern California

    collaborator OTHER
  • USDA, Western Human Nutrition Research Center

    collaborator FED
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of California, Davis

    lead OTHER

Principal Investigators

  • Peter J Havel, DVM, Ph.D · University of California, Davis

  • Jean-Marc Schwarz, Ph.D. · Touro University

  • Kimber L Stanhope, Ph.D. · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-03-13
Completion
2020-03-13

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02548767 on ClinicalTrials.gov