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Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overwt/Obese Adults (S37)

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ClinicalTrials.gov Identifier: NCT01951287
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Glucose Blood Insulin Other: Acute beverage (water) consumption Other: Acute beverage (Black Coffee) consumption Other: Acute beverage (Orange Juice) consumption Other: Acute beverage (Whole Milk) consumption Other: Acute beverage (2% Milk) consumption Other: Acute beverage (Skim Milk) consumption Not Applicable

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overweight/Obese Adults With Normal or Impaired Glucose Tolerance or Type 2 Diabetes
Study Start Date : August 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acute beverage (Water) consumption
Acute beverage (Water)consumption with breakfast measuring blood glucose and insulin levels at specific time points. consumption with breakfast measuring blood glucose and insulin levels at specific time points.
Other: Acute beverage (water) consumption
Acute beverage consumption includes water.
Experimental: Acute beverage (Black Coffee) consumption
Acute beverage (Black Coffee)consumption with breakfast measuring blood glucose and insulin levels at specific time points. consumption with breakfast measuring blood glucose and insulin levels at specific time points
Other: Acute beverage (Black Coffee) consumption
Acute beverage consumption includes black coffee.
Experimental: Acute beverage (Orange Juice) consumption
Acute beverage (Orange Juice)consumption with breakfast measuring blood glucose and insulin levels at specific time points. consumption with breakfast measuring blood glucose and insulin levels at specific time points
Other: Acute beverage (Orange Juice) consumption
Acute beverage consumption includes Orange Juice..
Experimental: Acute beverage (Whole Milk) consumption
Acute beverage (Whole Milk) consumption with breakfast measuring blood glucose and insulin levels at specific time points. consumption with breakfast measuring blood glucose and insulin levels at specific time points
Other: Acute beverage (Whole Milk) consumption
Acute beverage consumption includes whole milk
Experimental: Acute beverage (2% Milk) consumption
Acute beverage (2% Milk) consumption with breakfast measuring blood glucose and insulin levels at specific time points. consumption with breakfast measuring blood glucose and insulin levels at specific time points
Other: Acute beverage (2% Milk) consumption
Acute beverage consumption includes 2% milk
Experimental: Acute beverage (Skim Milk) consumption
Acute beverage (Skim Milk)consumption with breakfast measuring blood glucose and insulin levels at specific time points. consumption with breakfast measuring blood glucose and insulin levels at specific time points
Other: Acute beverage (Skim Milk) consumption
Acute beverage consumption includes skim milk



Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951287


Locations
United States, Indiana
Purdue University
West lafayette, Indiana, United States, 47906
Sponsors and Collaborators
Purdue University
Dairy Research Institute
Investigators
Principal Investigator: Wayne Campbell, PhD Purdue University

Additional Information:
Responsible Party: Wayne Campbell, Professor, Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT01951287     History of Changes
Other Study ID Numbers: 1303013430
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016