Replace Glycemic Load and Satiety Study

This study has been completed.
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01516333
First received: January 19, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Glucose Blood
Glycemic Index
Other: High GL 107
Other: Medium GL 76
Other: Medium GL 68
Other: Low GL 48
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Blood Glucose over time [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.


Secondary Outcome Measures:
  • Visual Analog scores (VAS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Hunger, satiety, and vigor will be measured by the visual analog scales.


Enrollment: 26
Study Start Date: February 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516333

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
General Mills Inc.
Investigators
Principal Investigator: Frank L Greenway, MD Pennington Biomedical Research Center
Study Chair: William Cefalu, MD Pennington Biomedial Research Center
Principal Investigator: Marlene M Most, PhD, RD Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frank Greenway, Medial Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01516333     History of Changes
Other Study ID Numbers: PBRC26026
Study First Received: January 19, 2012
Last Updated: January 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
glycemic Index

ClinicalTrials.gov processed this record on July 22, 2014