Replace Glycemic Load and Satiety Study

NCT ID: NCT01516333

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glucose Blood Glycemic Index

Keywords

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glycemic Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diet 1

High GI; High Carb; High GL

Group Type EXPERIMENTAL

High GL 107

Intervention Type OTHER

Three meals a day

Diet 2

High GI, Low Carb, Med GL

Group Type EXPERIMENTAL

Medium GL 76

Intervention Type OTHER

Three meals a day

Diet 3

Low GI, High Carb, Med GL

Group Type EXPERIMENTAL

Medium GL 68

Intervention Type OTHER

Three meals a day

Diet 4

Low GI, Low Carb, Low GL

Group Type EXPERIMENTAL

Low GL 48

Intervention Type OTHER

Three meals a day

Interventions

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High GL 107

Three meals a day

Intervention Type OTHER

Medium GL 76

Three meals a day

Intervention Type OTHER

Medium GL 68

Three meals a day

Intervention Type OTHER

Low GL 48

Three meals a day

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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General Mills

INDUSTRY

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Medial Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank L Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

William Cefalu, MD

Role: STUDY_CHAIR

Pennington Biomedial Research Center

Marlene M Most, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22688548 (View on PubMed)

Other Identifiers

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PBRC 26026

Identifier Type: -

Identifier Source: org_study_id