Replace Glycemic Load and Satiety Study

Glycemic Index Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516333
• Other study ID #: PBRC 26026
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2012
• Last updated: December 17, 2015
• Start date: February 2007
• Est. completion date: June 2007

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Blood
• Glycemic Index

Intervention

Other:
• High GL 107
Three meals a day
• Medium GL 76
Three meals a day
• Medium GL 68
Three meals a day
• Low GL 48
Three meals a day

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	General Mills Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose over time	Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.	1 month	No
Secondary	Visual Analog scores (VAS)	Hunger, satiety, and vigor will be measured by the visual analog scales.	1 month	No