Replace Glycemic Load and Satiety Study

Pennington Biomedical Research Center

Status and phase: Completed; Phase 1

Conditions: Glycemic Index; Glucose Blood

Treatments: Other: Medium GL 76; Other: Medium GL 68; Other: High GL 107; Other: Low GL 48

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01516333

PBRC 26026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Diet 1

Experimental group

Description:

High GI; High Carb; High GL

Treatment:

Other: High GL 107

Diet 2

Experimental group

Description:

High GI, Low Carb, Med GL

Treatment:

Other: Medium GL 76

Diet 3

Experimental group

Description:

Low GI, High Carb, Med GL

Treatment:

Other: Medium GL 68

Diet 4

Experimental group

Description:

Low GI, Low Carb, Low GL

Treatment:

Other: Low GL 48