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

NCT ID: NCT01951287

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-09-30

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).

Conditions

Blood Glucose; Blood Insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acute beverage (water) consumption

Intervention Type: OTHER

Acute beverage consumption includes water.

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

Group Type: EXPERIMENTAL

Acute beverage (Black Coffee) consumption

Intervention Type: OTHER

Acute beverage consumption includes black coffee.

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

Group Type: EXPERIMENTAL

Acute beverage (Orange Juice) consumption

Intervention Type: OTHER

Acute beverage consumption includes Orange Juice..

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

Group Type: EXPERIMENTAL

Acute beverage (Whole Milk) consumption

Intervention Type: OTHER

Acute beverage consumption includes whole milk

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

Group Type: EXPERIMENTAL

Acute beverage (2% Milk) consumption

Intervention Type: OTHER

Acute beverage consumption includes 2% milk

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

Group Type: EXPERIMENTAL

Acute beverage (Skim Milk) consumption

Intervention Type: OTHER

Acute beverage consumption includes skim milk

Interventions

Acute beverage (water) consumption

Acute beverage consumption includes water.

Intervention Type: OTHER

Acute beverage (Black Coffee) consumption

Acute beverage consumption includes black coffee.

Intervention Type: OTHER

Acute beverage (Orange Juice) consumption

Acute beverage consumption includes Orange Juice..

Intervention Type: OTHER

Acute beverage (Whole Milk) consumption

Acute beverage consumption includes whole milk

Intervention Type: OTHER

Acute beverage (2% Milk) consumption

Acute beverage consumption includes 2% milk

Intervention Type: OTHER

Acute beverage (Skim Milk) consumption

Acute beverage consumption includes skim milk

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dairy Research Institute

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Professor, Foods and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

1303013430

Identifier Type: -

Identifier Source: org_study_id