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

NCT02278042 | Completed

• 1 other identifier: 20131024
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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.

Other: Beverage Consumption

9% Glucose

ACTIVE COMPARATOR

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

Other: Beverage Consumption

Unsweetened Milk

ACTIVE COMPARATOR

Unsweetened milk consumed in amount the contributes 18% of the calories required for weight maintenance.

Other: Beverage Consumption

Interventions

Beverage Consumption OTHER

18% High fructose corn syrup; 18% Sucrose; 9% Fuctose; 9% Glucose; Unsweetened Milk

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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:

• 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.

Sponsors & Collaborators

• Rippe Lifestyle Institute: lead

Study Sites (1)

Rippe Lifestyle Institute

Celebration, Florida, 34747, United States

Location

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 1, 2013
• Primary Completion: March 1, 2015
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)