NCT01516333

Brief Summary

The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1

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

February 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

January 19, 2012

Last Update Submit

December 17, 2015

Conditions

Glucose BloodGlycemic Index

Keywords

glycemic Index

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose over time

    Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.

    1 month

Secondary Outcomes (1)

  • Visual Analog scores (VAS)

    1 month

Study Arms (4)

Diet 1

EXPERIMENTAL

High GI; High Carb; High GL

Other: High GL 107

Diet 2

EXPERIMENTAL

High GI, Low Carb, Med GL

Other: Medium GL 76

Diet 3

EXPERIMENTAL

Low GI, High Carb, Med GL

Other: Medium GL 68

Diet 4

EXPERIMENTAL

Low GI, Low Carb, Low GL

Other: Low GL 48

Interventions

High GL 107OTHER

Three meals a day

Diet 1
Medium GL 76OTHER

Three meals a day

Diet 2
Medium GL 68OTHER

Three meals a day

Diet 3
Low GL 48OTHER

Three meals a day

Diet 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass index between 25-35 kg/m2
  • Fasting serum glucose
  • Fasting serum glucose \< 125 mg/dl
  • Free of chronic disease
  • Willing to eat only the foods that are provided by the Center during the diet periods
  • Willing to abstain from the consumption of alcohol during the diet periods
  • Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
  • Monophasic birth control (same dose each day)
  • Hormone replacement therapy
  • Post-menopausal (over 1 year without bleeding)
  • Have had partial hysterectomy over the age of 55
  • complete hysterectomy at any age

You may not qualify if:

  • Documented presence of atherosclerotic disease
  • Diabetes mellitus
  • Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
  • Body Mass Index \<25 or \> 35
  • History of drug or alcohol abuse in the last year
  • For women, pregnancy, breast feeding or postpartum \< 6 months
  • History of depression or mental illness requiring treatment or medication within that last 6 months
  • Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
  • Lifestyle or schedule incompatible with the study protocol
  • Planned continued use of dietary supplements through the study trial
  • Smoking or tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Liu AG, Most MM, Brashear MM, Johnson WD, Cefalu WT, Greenway FL. Reducing the glycemic index or carbohydrate content of mixed meals reduces postprandial glycemia and insulinemia over the entire day but does not affect satiety. Diabetes Care. 2012 Aug;35(8):1633-7. doi: 10.2337/dc12-0329. Epub 2012 Jun 11.

    PMID: 22688548DERIVED

Study Officials

  • Frank L Greenway, MD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

  • William Cefalu, MD

    Pennington Biomedial Research Center

    STUDY CHAIR

  • Marlene M Most, PhD, RD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medial Principal Investigator

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 24, 2012

Study Start

February 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)