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

Blood Glucose Clinical Trial

— S37  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951287
• Other study ID #: 1303013430
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: February 4, 2016
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Glucose
• Blood Insulin

Intervention

Other:
• Acute beverage (water) consumption
Acute beverage consumption includes water.
• Acute beverage (Black Coffee) consumption
Acute beverage consumption includes black coffee.
• Acute beverage (Orange Juice) consumption
Acute beverage consumption includes Orange Juice..
• Acute beverage (Whole Milk) consumption
Acute beverage consumption includes whole milk
• Acute beverage (2% Milk) consumption
Acute beverage consumption includes 2% milk
• Acute beverage (Skim Milk) consumption
Acute beverage consumption includes skim milk

Locations

Country	Name	City	State
United States	Purdue University	West lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Dairy Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   for more information on the study, please go to the above link