Replace Glycemic Load and Satiety Study

Phase 1

Completed

• Conditions: Glycemic Index; Glucose Blood
• Interventions: Other: Medium GL 76; Other: Low GL 48; Other: High GL 107; Other: Medium GL 68

• Registration Number: NCT01516333
• Lead Sponsor: Pennington Biomedical Research Center

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.

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-24
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diet 2	Medium GL 76	High GI, Low Carb, Med GL
Diet 4	Low GL 48	Low GI, Low Carb, Low GL
Diet 1	High GL 107	High GI; High Carb; High GL
Diet 3	Medium GL 68	Low GI, High Carb, Med GL

Primary Outcome Measures

Name	Time	Method
Blood Glucose over time	1 month	Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.

Secondary Outcome Measures

Name	Time	Method
Visual Analog scores (VAS)	1 month	Hunger, satiety, and vigor will be measured by the visual analog scales.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States