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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Blood Glucose, Blood Insulin

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute beverage (Water) consumption<br>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<br>* Acute beverage consumption includes water.<br>|
| Experimental: Acute beverage (Black Coffee) consumption<br>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<br>* Acute beverage consumption includes black coffee.<br>|
| Experimental: Acute beverage (Orange Juice) consumption<br>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<br>* Acute beverage consumption includes Orange Juice..<br>|
| Experimental: Acute beverage (Whole Milk) consumption<br>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<br>* Acute beverage consumption includes whole milk<br>|
| Experimental: Acute beverage (2% Milk) consumption<br>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<br>* Acute beverage consumption includes 2% milk<br>|
| Experimental: Acute beverage (Skim Milk) consumption<br>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<br>* Acute beverage consumption includes skim milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose levels | 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. | 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Insulin Levels | 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. | 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial |