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

Not Applicable

Completed

• Conditions: Blood Insulin; Blood Glucose

• Registration Number: NCT01951287
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-26
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
plasma glucose levels	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

Name	Time	Method
Plasma Insulin Levels	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.

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West lafayette, Indiana, United States