Blood GlucoseS37NCT01951287
Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overwt/Obese Adults
A study testing Acute beverage (water) consumption, Acute beverage (Black Coffee) consumption and Acute beverage (Orange Juice) consumption in people with Blood Glucose and Blood Insulin, run by Purdue University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Blood Insulin
- What is being tested?
- Acute beverage (water) consumption, Acute beverage (Black Coffee) consumption and Acute beverage (Orange Juice) consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Acute beverage (water) consumption, Acute beverage (Black Coffee) consumption, Acute beverage (Orange Juice) consumption, Acute beverage (Whole Milk) consumption, Acute beverage (2% Milk) consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute beverage (water) consumptionOther
Acute beverage consumption includes water.
Acute beverage (Black Coffee) consumptionOther
Acute beverage consumption includes black coffee.
Acute beverage (Orange Juice) consumptionOther
Acute beverage consumption includes Orange Juice..
Acute beverage (Whole Milk) consumptionOther
Acute beverage consumption includes whole milk
Acute beverage (2% Milk) consumptionOther
Acute beverage consumption includes 2% milk
Acute beverage (Skim Milk) consumptionOther
Acute beverage consumption includes skim milk
| Study group | Role | What they receive |
|---|---|---|
| Acute beverage (Water) consumption | Experimental | 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. Receives: Other: Acute beverage (water) consumption |
| Acute beverage (Black Coffee) consumption | Experimental | 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 Receives: Other: Acute beverage (Black Coffee) consumption |
| Acute beverage (Orange Juice) consumption | Experimental | 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 Receives: Other: Acute beverage (Orange Juice) consumption |
| Acute beverage (Whole Milk) consumption | Experimental | 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 Receives: Other: Acute beverage (Whole Milk) consumption |
| Acute beverage (2% Milk) consumption | Experimental | 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 Receives: Other: Acute beverage (2% Milk) consumption |
| Acute beverage (Skim Milk) consumption | Experimental | 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 Receives: Other: Acute beverage (Skim Milk) consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Research Institute
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne Campbell, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951287
- Sponsor's protocol ID
- 1303013430
- Acronym
- S37
- Status last verified
- Feb 2016
- First submitted
- 12 Sep 2013
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01951287
- Acronym / sponsor ID
- S37 / 1303013430
- Conditions
- Blood Glucose, Blood Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Dairy Research Institute
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acute beverage (Water) consumption | Experimental | Other: Acute beverage (water) consumptionAcute 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 | Experimental | Other: Acute beverage (Black Coffee) consumptionAcute 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 | Experimental | Other: Acute beverage (Orange Juice) consumptionAcute 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 | Experimental | Other: Acute beverage (Whole Milk) consumptionAcute 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 | Experimental | Other: Acute beverage (2% Milk) consumptionAcute 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 | Experimental | Other: Acute beverage (Skim Milk) consumptionAcute 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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute beverage (water) consumptionAcute beverage consumption includes water. | Other | Acute beverage (Water) consumption |
| Acute beverage (Black Coffee) consumptionAcute beverage consumption includes black coffee. | Other | Acute beverage (Black Coffee) consumption |
| Acute beverage (Orange Juice) consumptionAcute beverage consumption includes Orange Juice.. | Other | Acute beverage (Orange Juice) consumption |
| Acute beverage (Whole Milk) consumptionAcute beverage consumption includes whole milk | Other | Acute beverage (Whole Milk) consumption |
| Acute beverage (2% Milk) consumptionAcute beverage consumption includes 2% milk | Other | Acute beverage (2% Milk) consumption |
| Acute beverage (Skim Milk) consumptionAcute beverage consumption includes skim milk | Other | Acute beverage (Skim Milk) consumption |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Campbell, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute beverage (water) consumption, Acute beverage (Black Coffee) consumption and Acute beverage (Orange Juice) consumption in people with Blood Glucose and Blood Insulin, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.