Glucose IntoleranceNCT01456754
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
A study testing low feeding frequency (3x) and High feeding frequency (14x) in people with Glucose Intolerance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- low feeding frequency (3x) and High feeding frequency (14x)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to Nov 2011
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI: 20-35 kg/m2
- Gender: Male
- Age: subjects has to be older than 18 and younger than 70 years old
- Impaired Glucose Tolerant (IGT) = plasma glucose, two hours after consuming 75g glucose, appears to be superior to 7.8mmol/l (normal level) but remains inferior to 11.1mmol/l (diabetes level) and fasting plasma glucose is less than 7.0mmol/l.
- Caucasian
Who cannot join
- Lactose intolerant
- Diabetes Mellitus
- Cardiovascular diseases
- Stomach and intestinal diseases
- Normal glucose levels after 2 hours
- Anticoagulants
- Medication that has a effect on energy and glucose homeostasis and absorption of foods
- Conditions or situations when subjects can't lose 500 ml blood
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.
- Conditions
- Glucose Intolerance
- Being tested
- low feeding frequency (3x), High feeding frequency (14x)
- Keywords
- Insulin Metabolism, Glucose Metabolism, Substrate Partitioning, Muscle Biopsies, Feeding Frequency, Insulin
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low feeding frequency (3x)Dietary supplement
3 meals a day
High feeding frequency (14x)Dietary supplement
14 meals a day
| Study group | Role | What they receive |
|---|---|---|
| High feeding frequency (14x) | Experimental | Not described Receives: Dietary Supplement: High feeding frequency (14x) |
| low feeding frequency (3x) | Experimental | Not described Receives: Dietary Supplement: low feeding frequency (3x) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism
Measured: 24 hour profile
Insulin metabolism
Measured: 24 hour profile
Secondary outcomes (2)
Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets
Measured: 24 hour profiles
Metabolic markers (FFA and TG metabolism)
Measured: 24 hour profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nederlandse Zuivel Organisatie
- Responsible party
- Sponsor
- Investigators
- Wim Saris, Prof. MD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456754
- Sponsor's protocol ID
- MEC 10-3-057
- Status last verified
- Dec 2011
- First submitted
- 26 Sep 2011
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
- ClinicalTrials.gov ID
- NCT01456754
- Acronym / sponsor ID
- MEC 10-3-057
- Conditions
- Glucose Intolerance
- Keywords
- Insulin Metabolism, Glucose Metabolism, Substrate Partitioning, Muscle Biopsies, Feeding Frequency, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Nederlandse Zuivel Organisatie
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Oct 2011 (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.
The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High feeding frequency (14x) | Experimental | Dietary Supplement: High feeding frequency (14x) |
| low feeding frequency (3x) | Experimental | Dietary Supplement: low feeding frequency (3x) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI: 20-35 kg/m2
- Gender: Male
- Age: subjects has to be older than 18 and younger than 70 years old
- Impaired Glucose Tolerant (IGT) = plasma glucose, two hours after consuming 75g glucose, appears to be superior to 7.8mmol/l (normal level) but remains inferior to 11.1mmol/l (diabetes level) and fasting plasma glucose is less than 7.0mmol/l.
- Caucasian
Key exclusion criteria (8 listed)
- Lactose intolerant
- Diabetes Mellitus
- Cardiovascular diseases
- Stomach and intestinal diseases
- Normal glucose levels after 2 hours
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 feeding frequency (3x)3 meals a day | Dietary supplement | low feeding frequency (3x) |
| High feeding frequency (14x)14 meals a day | Dietary supplement | High feeding frequency (14x) |
Primary outcome
Glucose metabolism
Time frame: 24 hour profile
Insulin metabolism
Time frame: 24 hour profile
2 secondary outcomes
Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets
Time frame: 24 hour profiles
Metabolic markers (FFA and TG metabolism)
Time frame: 24 hour profile
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 15 Dec 2011.
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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.
Wim Saris, Prof. MD 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 feeding frequency (3x) and High feeding frequency (14x) in people with Glucose Intolerance, run by Maastricht University Medical Center 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 5 inclusion and 8 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 15 Dec 2011. 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?
Glucose metabolism (time frame: 24 hour profile). 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 15 Dec 2011.