NCT01797042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

February 20, 2013

Last Update Submit

September 26, 2014

Conditions

Obesity

Keywords

FructoseHigh fructose corn syrupEnergy regulationEctopic fatUnderstandingpotential

Outcome Measures

Primary Outcomes (2)

  • Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid)

    Baseline and 10 weeks

  • Changes in fat content of skeletal muscle and liver

    Baseline and 10 weeks

Secondary Outcomes (3)

  • Change in body mass and body composition

    Baseline and 10 weeks

  • Change in fasting levels of biomarkers associated with obesity (glucose, insulin, C Reactive Protein (CRP), lipid panel)

    Baseline and 10 weeks

  • Change in glucose tolerance

    Baseline and 10 weeks

Study Arms (4)

Fructose 9%

ACTIVE COMPARATOR

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

Behavioral: Dietary Compliance

Glucose 9%

ACTIVE COMPARATOR

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

Behavioral: Dietary Compliance

High fructose corn syrup 18%

ACTIVE COMPARATOR

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

Behavioral: Dietary Compliance

Sucrose 18%

ACTIVE COMPARATOR

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

Behavioral: Dietary Compliance

Interventions

Dietary ComplianceBEHAVIORAL

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

Fructose 9%Glucose 9%High fructose corn syrup 18%Sucrose 18%

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI) 21.0 -33.0

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rippe Lifestyle Institute

Celebration, Florida, 34747, United States

Location

Related Publications (1)

  • 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.

    PMID: 25496265DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James M Rippe, MD

    Rippe Lifestyle Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

July 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations

US(1)