Replace Glycemic Load and Satiety Study

Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Index; Glucose Blood
• Intervention / Treatment: Other: High GL 107; Other: Medium GL 76; Other: Medium GL 68; Other: Low GL 48

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diet 1; High GI; High Carb; High GL	Other: High GL 107; Three meals a day
EXPERIMENTAL: Diet 2; High GI, Low Carb, Med GL	Other: Medium GL 76; Three meals a day
EXPERIMENTAL: Diet 3; Low GI, High Carb, Med GL	Other: Medium GL 68; Three meals a day
EXPERIMENTAL: Diet 4; Low GI, Low Carb, Low GL	Other: Low GL 48; Three meals a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog scores (VAS)	Hunger, satiety, and vigor will be measured by the visual analog scales.	1 month

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: General Mills
• Investigators: Study Chair: William Cefalu, MD, Pennington Biomedial Research Center; Principal Investigator: Marlene M Most, PhD, RD, Pennington Biomedical Research Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): June 1, 2007
• Study Completion (ACTUAL): June 1, 2007

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (ESTIMATE): January 24, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: glycemic Index
• Other Study ID Numbers: PBRC 26026