Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overweight/Obese Adults With Normal or Impaired Glucose Tolerance or Type 2 Diabetes (S37)

This study is currently recruiting participants.
Verified September 2013 by Purdue University
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01951287
First received: September 12, 2013
Last updated: September 23, 2013
Last verified: September 2013

September 12, 2013
September 23, 2013
August 2013
October 2013   (final data collection date for primary outcome measure)
plasma glucose levels [ Time Frame: 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial ] [ Designated as safety issue: No ]
Subjects will come to testing once a week for six weeks. Each testing day, subject will come in fasted, and a fasting blood draw will be taken. Subjects will then be fed a standard breakfast with one of the 6 beverages (coffee sweetened with sugar, orange juice, water, whole milk, skim milk, low fat milk). Blood will be taken at 30, 60, 60, 90, 120, 150,180,210,240 minutes after the meal.
Same as current
Complete list of historical versions of study NCT01951287 on ClinicalTrials.gov Archive Site
Plasma Insulin Levels [ Time Frame: 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial ] [ Designated as safety issue: No ]
Subjects will come to testing once a week for six weeks. Each testing day, subject will come in fasted, and a fasting blood draw will be taken. Subjects will then be fed a standard breakfast with one of the 6 beverages (coffee sweetened with sugar, orange juice, water, whole milk, skim milk, low fat milk). Blood will be taken at 30, 60, 60, 90, 120, 150,180,210,240 minutes after the meal.
Same as current
Not Provided
Not Provided
 
Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overweight/Obese Adults With Normal or Impaired Glucose Tolerance or Type 2 Diabetes
Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overweight/Obese Adults With Normal or Impaired Glucose Tolerance or Type 2 Diabetes

Blood sugar and insulin levels after a meal may be altered by the food and beverages a person consumes. Keeping a healthy blood sugar level may help prevent and manage type 2 diabetes and related diseases. This study will look at how drinking different common beverages (milk, low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal changes blood sugar and insulin levels.

The broad aim of the proposed research is to evaluate the effects of consuming milk and non-milk beverages with a breakfast meal on postprandial glucose and insulin responses in overweight and obese adults with varying levels of glucose tolerance (normal, pre-diabetic, type 2 diabetes). The investigators expect the consumption of fluid milk with breakfast to decrease the postprandial glucose response relative to other non-milk beverages (orange juice and sweetened coffee). Furthermore, the investigators expect that there will be no difference in the postprandial glucose or insulin response between varieties of fluid milk (skim, low-fat, and whole).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
  • Blood Glucose
  • Blood Insulin
Other: Acute beverage consumption with a breakfast meal
Subjects will be provided with breakfast with one of the six test beverages in a random order on six mornings. On each test day, a catheter will be placed in an antecubital vein prior to consuming breakfast. Blood samples will be collected prior to breakfast, and at 30, 60, 90, 120, 150, 180, 210, and 240 minutes after completing the meal (100ml total).
Experimental: Acute beverage consumption
Acute beverage consumption with breakfast measuring blood glucose and insulin levels at specific time points.
Intervention: Other: Acute beverage consumption with a breakfast meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
March 2015
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 35-65 years old,
  • BMI between 27-40 kg/m2,
  • HbA1C less than 7.5%,
  • weight stable (± 4.5 kg) for the previous 3 months
  • willing to consume study foods and beverages.

Exclusion Criteria:

  • using exogenous insulin,
  • currently (or within the past 6 months) following a vigorous exercise regimen, or weight loss program,
  • acute illness,
  • smoking,
  • pregnant or planning pregnancy in the next 3 months,
  • lactose intolerant,
  • weight changes of greater than ± 3 kg during the study period
Both
35 Years to 65 Years
Yes
Contact: Wayne Campbell, PhD 7654948236 campbellw@purdue.edu
Contact: Jia Li, Masters 7654947922 li1201@purdue.edu
United States
 
NCT01951287
1303013430
No
Wayne Campbell, Purdue University
Purdue University
Dairy Research Institute
Principal Investigator: Wayne Campbell, PhD Purdue University
Purdue University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP