A Comparison of the Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels in Adults Aged 20-60 Years Old

NCT ID: NCT01797042

Last Updated: 2014-09-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the acute and chronic effects of consumption fructose containing sugars and glucose in a real word setting when consumed in a manner and amount typical in the American diet.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fructose is known to be metabolized differently than the other common monosaccharides. In addition to the well know lipogenic effects, more recent evidence has shown that the acute changes in hormones and metabolic parameters that control appetite and energy regulation when with fructose consumption may promote caloric overconsumption and, in the long-term, weight gain. However, fructose is rarely consumed in isolation, but instead is consumed in combination with other sugars (with glucose in the case of the two most common sources of fructose: high fructose corn syrup (HFCS) and sucrose, or as part of a mixed macronutrient meal. As such, the practical significance of these short-term findings of isolated monosaccharide consumption is limited.

AIM 1: investigate the response to ten weeks of daily consumption of different fructose containing sugars and glucose at typical intake levels on various metabolic parameters and on fat content of the liver and skeletal muscle.

AIM 2: To investigate whether ten weeks of daily consumption changes the acute metabolic response when these sugars are consumed as part as mixed nutrient meals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fructose High fructose corn syrup Energy regulation Ectopic fat Understanding potential

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fructose 9%

Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance

Group Type ACTIVE_COMPARATOR

Dietary Compliance

Intervention Type BEHAVIORAL

Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks

Glucose 9%

Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance

Group Type ACTIVE_COMPARATOR

Dietary Compliance

Intervention Type BEHAVIORAL

Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks

High fructose corn syrup 18%

Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance

Group Type ACTIVE_COMPARATOR

Dietary Compliance

Intervention Type BEHAVIORAL

Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks

Sucrose 18%

Sugar sweetened milk consumed in an amount that added sugar provides 9% of calories required for weight maintenance

Group Type ACTIVE_COMPARATOR

Dietary Compliance

Intervention Type BEHAVIORAL

Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary Compliance

Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body Mass Index (BMI) 21.0 -33.0

Exclusion Criteria

* More than a 3% change in weight within the 3 months prior to enrollment in the study.
* Currently smoking cigarettes
* Currently taking any prescription medication for less than 3 months.
* Currently taking a prescription medication for weight loss (4 week wash out period required).
* Currently taking any over-the-counter weight loss supplement/s (2 week wash out period required).
* History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months.
* Diagnosed with Type I or Type II diabetes or prediabetes.
* Major surgery within three months of enrollment.
* History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
* Presence of implanted cardiac defibrillator or pacemaker.
* Uncontrolled hypertension/high blood pressure.
* History of a surgical procedure for weight loss at any time.
* Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
* History of inflammatory bowel disease
* History of fatty liver
* History or presence of cancer (except for successfully resected basal cell carcinoma of the skin more than 6 months prior to enrollment).
* History of clinically diagnosed eating disorders including anorexia nervosa, bulimia nervosa or binge eating disorder.
* Women who are pregnant, lactating or trying to become pregnant.
* History of alcohol dependency
* Currently consuming \>14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and/or unwilling to limit intake to less than 3 drinks per week during study participation.
* Lactose intolerance
* Known allergy to HFCS, sucrose, fructose or glucose.
* Any clinically significant food allergy
* Participation in another clinical trial within 30 days prior to enrollment.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rippe Lifestyle Institute

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James M Rippe, MD

Role: PRINCIPAL_INVESTIGATOR

Rippe Lifestyle Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rippe Lifestyle Institute

Celebration, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Angelopoulos TJ, Lowndes J, Sinnett S, Rippe JM. Fructose containing sugars do not raise blood pressure or uric acid at normal levels of human consumption. J Clin Hypertens (Greenwich). 2015 Feb;17(2):87-94. doi: 10.1111/jch.12457. Epub 2014 Dec 15.

Reference Type DERIVED
PMID: 25496265 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20122091

Identifier Type: -

Identifier Source: org_study_id