Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overwt/Obese Adults
S37
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFebruary 8, 2016
February 1, 2016
2.1 years
September 12, 2013
February 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Plasma Insulin Levels
6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial
Study Arms (6)
Acute beverage (Water) consumption
EXPERIMENTALAcute 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.
Acute beverage (Black Coffee) consumption
EXPERIMENTALAcute 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
Acute beverage (Orange Juice) consumption
EXPERIMENTALAcute 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
Acute beverage (Whole Milk) consumption
EXPERIMENTALAcute 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
Acute beverage (2% Milk) consumption
EXPERIMENTALAcute 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
Acute beverage (Skim Milk) consumption
EXPERIMENTALAcute 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
Interventions
Acute beverage consumption includes water.
Acute beverage consumption includes black coffee.
Acute beverage consumption includes Orange Juice..
Acute beverage consumption includes whole milk
Acute beverage consumption includes 2% milk
Acute beverage consumption includes skim milk
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Universitylead
- Dairy Research Institutecollaborator
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47906, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne Campbell, PhD
Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Foods and Nutrition
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 26, 2013
Study Start
August 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
February 8, 2016
Record last verified: 2016-02