Glucose RegulationNCT02011672
Effect of Milk Ingredients on Glucose Regulation and Inflammation
A study testing nutrient-enriched milk and regular milk in people with Glucose Regulation and Low-grade Inflammation, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
Background: Recent advances in science have established a fundamental role for low grade chronic inflammation in mediating all stages of most of the non-communicable diseases associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Regulation, Low-grade Inflammation
- What is being tested?
- nutrient-enriched milk and regular milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to Jun 2014
- 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 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 28-35 kg/m2
- Waist circumference >102 cm
- Healthy as assessed by the NIZO lifestyle and health questionnaire and results of the pre-study safety laboratory tests.
- Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
- Habitual consumption of dairy products as assessed by dietary questionnaire
- Voluntary participation
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- Having given written informed consent
- Willing to comply with study procedures
- Access to internet
- Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years.
- Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned
Who cannot join
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous or inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal strictures
- Medical drug use; antibiotics, laxatives, glucose lowering drugs, insulin; all medication with an inflammation inhibiting effect (e.g. NSAIDS, corticosteroids) and/or an effect on blood coagulation (e.g. coumarins, inhibitors of thrombin or factor Xa, acetylsalicylic acid, antidepressants from the group of serotonin reabsorption inhibitors, tranexamin acid)
- Mental status that is incompatible with the proper conduct of the study
- A self-reported reported food allergy or sensitivity (wheat, milk, lactose, eggs, nuts, etc)
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- Alcohol consumption > 28 units/week and 4/day
- Exercise > 3 hours/week
- Smoking >20 cigarettes/day
- Reported unexplained weight loss or weight gain of > 3 kg in the month prior to pre-study screening
- Reported slimming or medically prescribed diet
- Reported vegan or macrobiotic life-style
- Recent blood donation (<1 month prior to Day 01 of the study)
- Not willing or afraid to give up blood donation during the study
- Personnel of NIZO food research or Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Milk Ingredients on Glucose Regulation and Inflammation in Overweight Subjects
Background: Recent advances in science have established a fundamental role for low grade chronic inflammation in mediating all stages of most of the non-communicable diseases associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy and its components are known to exert beneficial effects on postprandial hyperglycemia. This study investigates if dairy, normal and enriched, can reduce chronic inflammation via improvement in glucose regulation.
Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose regulation and postprandial inflammation with the effect of a standard milk drink, within a population of overweight, apparently healthy subjects.
Read more
Study design: The study is designed as a double-blind randomized placebo-controlled parallel trial during 7 weeks, during which the test and reference products will be consumed at home.
Main study parameters/endpoints: The difference in absolute change in fasting blood plasma concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the treatment period, between subjects consuming the test and reference product.
- Conditions
- Glucose Regulation, Low-grade Inflammation
- Being tested
- nutrient-enriched milk, regular milk
- Keywords
- dairy, glucose, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrient-enriched milkOther
regular milkOther
| Study group | Role | What they receive |
|---|---|---|
| nutrient-enriched milk | Experimental | consumption of 250 ml three times per day Receives: Other: nutrient-enriched milk |
| regular milk | Placebo comparator | consumption of 250 ml three times per day Receives: Other: regular milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fasting blood glucose
Measured: baseline and 7 weeks
change in fasting plasma interleukin-6 (IL-6)
Measured: baseline and 7 weeks
Secondary outcomes (4)
postprandial area under the curve for plasma glucose
Measured: 7 weeks
change in fasting insulin
Measured: 7 weeks
postprandial area under the curve for plasma insulin
Measured: 7 weeks
postprandial area under the curve for plasma IL-6
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose RegulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Principal investigator, Alwine Kardinaal, NIZO Food Research
- Investigators
- Alwine Kardinaal, PhD, Principal investigator, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011672
- Sponsor's protocol ID
- NL46103.081.13
- Status last verified
- Sep 2014
- First submitted
- 10 Dec 2013
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk Ingredients on Glucose Regulation and Inflammation in Overweight Subjects
- ClinicalTrials.gov ID
- NCT02011672
- Acronym / sponsor ID
- NL46103.081.13
- Conditions
- Glucose Regulation, Low-grade Inflammation
- Keywords
- dairy, glucose, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Dec 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.
Background: Recent advances in science have established a fundamental role for low grade chronic inflammation in mediating all stages of most of the non-communicable diseases associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy and its components are known to exert beneficial effects on postprandial hyperglycemia. This study investigates if dairy, normal and enriched, can reduce chronic inflammation via improvement in glucose regulation.
Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose regulation and postprandial inflammation with the effect of a standard milk drink, within a population of overweight, apparently healthy subjects.
Study design: The study is designed as a double-blind randomized placebo-controlled parallel trial during 7 weeks, during which the test and reference products will be consumed at home.
Main study parameters/endpoints: The difference in absolute change in fasting blood plasma concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the treatment period, between subjects consuming the test and reference product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutrient-enriched milk | Experimental | Other: nutrient-enriched milkconsumption of 250 ml three times per day |
| regular milk | Placebo comparator | Other: regular milkconsumption of 250 ml three times per day |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- BMI 28-35 kg/m2
- Waist circumference >102 cm
- Healthy as assessed by the NIZO lifestyle and health questionnaire and results of the pre-study safety laboratory tests.
- Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
- Habitual consumption of dairy products as assessed by dietary questionnaire
Key exclusion criteria (17 listed)
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous or inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal strictures
- Medical drug use; antibiotics, laxatives, glucose lowering drugs, insulin; all medication with an inflammation inhibiting effect (e.g. NSAIDS, corticosteroids) and/or an effect on blood coagulation (e.g. coumarins, inhibitors of thrombin or factor Xa, acetylsalicylic acid, antidepressants from the group of serotonin reabsorption inhibitors, tranexamin acid)
- Mental status that is incompatible with the proper conduct of the study
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 |
|---|---|---|
| nutrient-enriched milk | Other | nutrient-enriched milk |
| regular milk | Other | regular milk |
Primary outcome
change in fasting blood glucose
Time frame: baseline and 7 weeks
change in fasting plasma interleukin-6 (IL-6)
Time frame: baseline and 7 weeks
4 secondary outcomes
postprandial area under the curve for plasma glucose
Time frame: 7 weeks
change in fasting insulin
Time frame: 7 weeks
postprandial area under the curve for plasma insulin
Time frame: 7 weeks
postprandial area under the curve for plasma IL-6
Time frame: 7 weeks
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 9 Sep 2014.
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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.
Alwine Kardinaal, PhD principal investigator
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrient-enriched milk and regular milk in people with Glucose Regulation and Low-grade Inflammation, run by NIZO Food Research at 1 site in Netherlands.
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 11 inclusion and 17 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 9 Sep 2014. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
change in fasting blood glucose (time frame: baseline and 7 weeks). The study lists 2 primary outcomes in all. 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 9 Sep 2014.