Clinical trial NCT01516333: Replace Glycemic Load and Satiety Study
Official title: Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glucose Blood
Glycemic Index
Keywords: glycemic Index
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2012-01-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Glucose over time
timeFrame: 1 month
Secondary outcomes:
measure: Visual Analog scores (VAS)
timeFrame: 1 month
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank L Greenway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedial Research Center
name: William Cefalu, MD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Marlene M Most, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.