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Completed

NCT Number: NCT01951287

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

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.

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Key information

Conditions

Blood Glucose Blood Insulin

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47906, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute beverage (water) consumption

Other

Acute beverage consumption includes water.

Acute beverage (Black Coffee) consumption

Other

Acute beverage consumption includes black coffee.

Acute beverage (Orange Juice) consumption

Other

Acute beverage consumption includes Orange Juice..

Acute beverage (Whole Milk) consumption

Other

Acute beverage consumption includes whole milk

Acute beverage (2% Milk) consumption

Other

Acute beverage consumption includes 2% milk

Acute beverage (Skim Milk) consumption

Other

Acute beverage consumption includes skim milk

Primary outcomes

  1. plasma glucose levels

    Time frame: 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial

    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.

Secondary outcomes

  1. Plasma Insulin Levels

    Time frame: 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial

    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.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Dairy Research Institute

Registry information

Official study 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

Acronym: S37

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2013
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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