Trials Sponsors Conditions Drugs Pricing

Conditions

Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing Sugars

Outcome Measures

Primary Outcomes (2)

Change in glucose tolerance
Change in glucose Area Under the Curve (AUC) in response to a standard 2 hour Oral Glucose Tolerance Test
10 weeks (Baseline and week 10)
Change in Insulin Sensitivity
Change in 1) insulin AUC in response to a standard 2 hour Oral Glucose and Matsuda Insulin Sensitivity Index
10 weeks (Baseline and week 10)

Secondary Outcomes (4)

Change in fat content of the liver
10 weeks (baseline and Week 10)
Change in fat content of the abdomen
10 weeks (baseline and Week 10)
Change in fat content of the skeletal muscles
10 weeks (baseline and Week 10)
Change in hypothalamic activity
10 weeks (baseline and Week 10)

Study Arms (5)

9% Fuctose

ACTIVE COMPARATOR

Milk Sweetened with fructose in an amount that the added fructose contributes 9% of the calories required for weight maintenance.

Other: Beverage Consumption

18% Sucrose

ACTIVE COMPARATOR

Milk Sweetened with sucrose in an amount that the added sucrose contributes 18% of the calories required for weight maintenance.

Other: Beverage Consumption

18% High fructose corn syrup

ACTIVE COMPARATOR

Milk Sweetened with High fructose corn syrup (HFCS) in an amount that the added HFCS contributes 18% of the calories required for weight maintenance.

Interventions

Beverage ConsumptionOther

18% High fructose corn syrup18% Sucrose9% Fuctose9% GlucoseUnsweetened Milk

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Eligibility Criteria

Age20 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female between the ages of 20-60 years of age.
Body Mass Index (BMI) 21.0 - 35.0

You may not qualify if:

Sponsors & Collaborators

Rippe Lifestyle Institute
Industrylead

Study Sites (1)

Rippe Lifestyle Institute

Celebration, Florida, 34747, United States

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 29, 2014

Study Start

June 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2015

Actual (reported)

More than a 3 percent change in weight within the 3 months prior to enrollment in the study.
History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
Currently taking a prescription medication for weight loss. If subject is willing to discontinue prescription medication(s) immediately and willing to refrain from taking medication(s) for duration of study, he/she may be enrolled after a four-week washout period.
Currently taking any over-the-counter weight loss supplement(s). If subject is willing to discontinue supplement(s) immediately and willing to refrain from taking supplement(s) for duration of study, he/she may be enrolled after a two-week washout period.
Currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous). If subject is willing to discontinue program immediately and willing to refrain from program for duration of study, he/she may be included after a two-week washout period.
Diagnosed with prediabetes or frank diabetes (Type I or Type II).
History of 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 (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy).
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. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.
+10 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (5)

9% Fuctose

18% Sucrose

18% High fructose corn syrup

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

9% Glucose

Unsweetened Milk

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (5)

9% Fuctose

18% Sucrose

18% High fructose corn syrup

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

9% Glucose

Unsweetened Milk

Source record

Locations