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. (see Contacts and Locations)
Verified July 2014 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: July 9, 2014
Last verified: July 2014
  Purpose

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 Intervention
Blood Glucose
Blood Insulin
Other: Acute beverage consumption with a breakfast meal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
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

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 70
Study Start Date: August 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute beverage consumption
Acute beverage consumption with breakfast measuring blood glucose and insulin levels at specific time points.
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).

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).

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
  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: NCT01951287

Contacts
Contact: Wayne Campbell, PhD 7654948236 campbellw@purdue.edu
Contact: Jia Li, Masters 7654947922 li1201@purdue.edu

Locations
United States, Indiana
Purdue University Recruiting
West lafayette, Indiana, United States, 47906
Contact: Wayne Campbell, PhD    765-494-8236    campbellw@purdue.edu   
Contact: Jia Li, Masters    7654947922    li1201@purdue.edu   
Principal Investigator: Wayne Campbell, PhD         
Sponsors and Collaborators
Purdue University
Dairy Research Institute
Investigators
Principal Investigator: Wayne Campbell, PhD Purdue University
  More Information

Additional Information:
No publications provided

Responsible Party: Wayne Campbell, Professor, Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT01951287     History of Changes
Other Study ID Numbers: 1303013430
Study First Received: September 12, 2013
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Overweight
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Hyperglycemia

ClinicalTrials.gov processed this record on September 18, 2014