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

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose; Blood Insulin
• Intervention / Treatment: 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

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
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West lafayette, Indiana, United States, 47906
      • Purdue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: Dairy Research Institute
• Investigators: Principal Investigator: Wayne Campbell, PhD, Purdue University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1303013430