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CompletedNCT01516333Updated Dec 18, 2015

Replace Glycemic Load and Satiety Study

A Phase 1 interventional study of High GL 107 and Medium GL 76 in Glucose Blood and Glycemic Index, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-18.

Sponsored by Pennington Biomedical Research Center · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.

02

Conditions studied

  • Glucose Blood
  • Glycemic Index

Keywords

  • glycemic Index
03

In context

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Diet 1

    High GI; High Carb; High GL

    Other: High GL 107

  • Experimental
    Diet 2

    High GI, Low Carb, Med GL

    Other: Medium GL 76

  • Experimental
    Diet 3

    Low GI, High Carb, Med GL

    Other: Medium GL 68

  • Experimental
    Diet 4

    Low GI, Low Carb, Low GL

    Other: Low GL 48

Interventions

  • OtherHigh GL 107

    Three meals a day

  • OtherMedium GL 76

    Three meals a day

  • OtherMedium GL 68

    Three meals a day

  • OtherLow GL 48

    Three meals a day

06

What researchers measure

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.

    Time frame: 1 month

Secondary outcomes

  1. Visual Analog scores (VAS)

    Hunger, satiety, and vigor will be measured by the visual analog scales.

    Time frame: 1 month

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

References and documents

Publications

  • 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. PubMed 22688548 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2007, a primary completion of Jun 2007 and a completion of Jun 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2012
First posted
Jan 24, 2012
Start
Feb 2007
Primary completionActual
Jun 2007
CompletionActual
Jun 2007
Last update
Dec 18, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01516333
Lead sponsor
Pennington Biomedical Research Center
Collaborators
General Mills
Responsible party
Frank Greenway (Medial Principal Investigator, Pennington Biomedical Research Center) — Principal investigator
First posted
Jan 24, 2012
Start date
Feb 2007
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Dec 18, 2015

Study contacts

Frank L Greenway, MD
principal investigator · Pennington Biomedical Research Center
William Cefalu, MD
study chair · Pennington Biomedial Research Center
Marlene M Most, PhD, RD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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