Glucose Metabolism DisordersGLOWNCT02926118
Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
A study testing Low glycemic load and High glycemic load in people with Glucose Metabolism Disorders, run by Unilever R&D at 1 site in Netherlands.
Trial summary
This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Low glycemic load and High glycemic load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Apr 2017to 18 Oct 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy males and post-menopausal females
- Age at start of the study ≥ 50 and ≤ 70 years
- Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2
- Fasting blood glucose value of subjects is ≥ 3.4 and < 6.1 mmol/L at screening
- Being used to eat three meals a day
- Having a general practitioner
- Agreeing to be informed about medically relevant personal test-results by a physician
- Accessible veins on arms as determined by examination at screening.
Who cannot join
- Having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician
- Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator
- Use of oral antibiotics in 40 days or less prior to the start of the study
- Reported participation in another nutritional or biomedical study 3 months before the screening or during the study
- Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between mid-night and 6.00 am
- Reported intense sporting activities > 2h/w. Intense sporting activities are defined as those activities that cause a lack of breath which limits the ability to have a normal conversation
Show all 13Show fewer
- Reported alcohol consumption > 10 units/week (female) or > 14 units/week (male)
- Reported use of any nicotine containing products in the 6 months preceding the study and willing to abstain from use of nicotine containing products during the study itself
- Reported dietary habits: medically prescribed diet, slimming diet, vegetarian
- Reported weight loss/gain (> 3 kg) in the last 2 months before the study
- Being an employee of Unilever or research departments in NUTRIM or the Maastricht University Medical Centre (MUMC+) collaborating in this study
- Known allergy or intolerance to food products.
- Blood donation in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.
Read the detailed description
The aim of this study is to determine the suitability of a continuous glucose monitor to detect the impact of a dietary intervention on postprandial blood glucose levels in normal, healthy, free living subjects. We will compare a dietary intervention of meals with a high glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low post-meal blood glucose) in a cross-over study. In addition, the glucose profiles obtained both via venous blood sampling and via continuous glucose monitor following a standard carbohydrate load will be compared.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Low glycemic load, High glycemic load
- Keywords
- Glucose, Continuous glucose monitor, Glycemic load, Dietary intervention
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic loadDietary supplement
Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
High glycemic loadDietary supplement
High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic load | Experimental | Low glycemic load Receives: Dietary Supplement: Low glycemic load |
| High glycemic load | Experimental | High glycemic load Receives: Dietary Supplement: High glycemic load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post prandial glucose concentration
Difference in glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after the three main meals (breakfast, lunch, dinner) during both dietary interventions will be calculated. The nine post prandial periods for both low and high glycemic load diet per subject will be combined in the mixed model.
Measured: 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)
Secondary outcomes (5)
Three-day glucose concentration
Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared
Measured: From start of dietary intervention until the end 3 days later
Day time glucose concentration
Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared
Measured: Between 07:00-22:00 h
Night time glucose concentration
Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared
Measured: Between 22:01-26:59 h
Glucose variability
The Continuous Overall Net Glycemic Action (CONGA) will be calculated.
Measured: From start of dietary intervention until the end 3 days later
Comparison of continuous interstitial glucose with venous blood glucose
Bland-Altman plots of venous blood glucose plotted against the continuous interstitial glucose at the closest available time point. Standard meal will be 200 grams of rice consumed on the day after both the low and high glycemic load diets
Measured: -30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start27 Apr 2017
- Primary completion13 Jul 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Mensink Ronald P, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926118
- Sponsor's protocol ID
- REF-CSC-2682
- Acronym
- GLOW
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2016
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
- ClinicalTrials.gov ID
- NCT02926118
- Acronym / sponsor ID
- GLOW / REF-CSC-2682
- Conditions
- Glucose Metabolism Disorders
- Keywords
- Glucose, Continuous glucose monitor, Glycemic load, Dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Maastricht University
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 6 Oct 2016 (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.
This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.
Detailed description
The aim of this study is to determine the suitability of a continuous glucose monitor to detect the impact of a dietary intervention on postprandial blood glucose levels in normal, healthy, free living subjects. We will compare a dietary intervention of meals with a high glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low post-meal blood glucose) in a cross-over study. In addition, the glucose profiles obtained both via venous blood sampling and via continuous glucose monitor following a standard carbohydrate load will be compared.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic load | Experimental | Dietary Supplement: Low glycemic loadLow glycemic load |
| High glycemic load | Experimental | Dietary Supplement: High glycemic loadHigh glycemic load |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Apparently healthy males and post-menopausal females
- Age at start of the study ≥ 50 and ≤ 70 years
- Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2
- Fasting blood glucose value of subjects is ≥ 3.4 and < 6.1 mmol/L at screening
- Being used to eat three meals a day
Key exclusion criteria (13 listed)
- Having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician
- Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator
- Use of oral antibiotics in 40 days or less prior to the start of the study
- Reported participation in another nutritional or biomedical study 3 months before the screening or during the study
- Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between mid-night and 6.00 am
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 |
|---|---|---|
| Low glycemic loadLow glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days | Dietary supplement | Low glycemic load |
| High glycemic loadHigh glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days | Dietary supplement | High glycemic load |
Primary outcome
Post prandial glucose concentration
Time frame: 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)
Difference in glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after the three main meals (breakfast, lunch, dinner) during both dietary interventions will be calculated. The nine post prandial periods for both low and high glycemic load diet per subject will be combined in the mixed model.
5 secondary outcomes
Three-day glucose concentration
Time frame: From start of dietary intervention until the end 3 days later
Day time glucose concentration
Time frame: Between 07:00-22:00 h
Night time glucose concentration
Time frame: Between 22:01-26:59 h
Glucose variability
Time frame: From start of dietary intervention until the end 3 days later
Comparison of continuous interstitial glucose with venous blood glucose
Time frame: -30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal
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 19 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Mensink Ronald P, PhD principal investigator
Maastricht 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 Low glycemic load and High glycemic load in people with Glucose Metabolism Disorders, run by Unilever R&D 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 8 inclusion and 13 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 19 Oct 2017. 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. 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?
Post prandial glucose concentration (time frame: 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)). 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 19 Oct 2017.