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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01951287
Other study ID # 1303013430
Secondary ID
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


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
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