ObesityNCT00229255
Relation of Obesity With Frequency of Meals (MST 0557)
A study testing high frequency of meals and twice a day meals in people with Obesity and Insulin Resistance, run by Rockefeller University at 1 site in United States.
Trial summary
The purpose of this study is to test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We, the researchers at Rockefeller University, hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent insulin resistance and reduce hepatic lipid… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Fatty Liver
- What is being tested?
- high frequency of meals and twice a day meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2009
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Age between 18-45 years
- Body mass index (BMI) between 18.5 - 24.9
Who cannot join
- Diabetes mellitus
- Chronic drug treatment for any medical condition like hypertension or hyperlipidemia, hyperthyroidism or taking weight control medications.
- Inability to give informed consent.
- Inability to give contact information including permanent residence or provide evidence of stable living environment for the study period.
- Active weight reduction of more than 7 pounds in the last 3 months.
- History of bleeding or blood clotting disorders.
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- Pregnancy or breast-feeding in the women.
- History of anaphylaxis or anaphylactoid-like reaction as a result of food allergies.
- HIV or hepatitis B and C positive subjects.
- Subjects with hemoglobin < 8.5 gm/dl.
- Abnormal liver function test (ALT, AST, alkaline phosphate, LDH, GGT or total bilirubin).
- Serum creatinine or BUN greater than the upper limit of the normal, serum albumin less than 3.5g/dl, or proteinuria 1+ or greater.
- History of alcohol intake of more than 40 g/day.
- Contraindications to magnetic resonance imaging (MRI) including pacemakers, surgical clips, metallic implants, neuromuscular- skeletal stimulators and internal orthopedic screws or rods.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10021
About this study
The purpose of this study is to test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We, the researchers at Rockefeller University, hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.
This is a 6 week inpatient study.
Read the detailed description
The hypothesis will be tested by studying two groups of normal subjects who will receive a defined weight maintenance diet: one group will be given meals twice a day and other group will be given eight meals (snacks) per day. At the beginning of the study period and after 4 weeks following the specified frequency of meals, the study subjects will have their whole body insulin sensitivity and hepatic fat content measured by the euglycemic-hyperinsulinemic clamp and MRI of the liver, respectively.
- Conditions
- Obesity, Insulin Resistance, Fatty Liver
- Being tested
- high frequency of meals, twice a day meals
- Keywords
- Non-Alcoholic hepatic steatosis
- Medical subject headings
- Obesity, Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency of mealsOther
high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
twice a day mealsOther
high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| high frequency meals group | Active comparator | High carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks. Receives: Other: high frequency of meals |
| twice-a -day meals | Active comparator | high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks Receives: Other: twice a day meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will determine total body insulin sensitivity with the help of the hyperinsulinemic-euglycemic clamp. We will also assess hepatic steatosis by conducting MRI scans on our subjects.
Measured: days 8,9,11 41 and 42
Secondary outcomes (1)
Weight, waist and hip circumference, fasting glucose and insulin, serum ketones, lipids and lipoproteins including VLDL and apolipoprotien B100, liver function tests, serum adiponectin (marker for insulin resistance), and measures of hunger.
Measured: days 1-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Sponsor
- Investigators
- Markus Stoffel, MD, PHD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229255
- Sponsor's protocol ID
- MST-0557
- Status last verified
- May 2012
- First submitted
- 27 Sep 2005
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Obesity With Frequency of Meals (MST 0557)
- ClinicalTrials.gov ID
- NCT00229255
- Acronym / sponsor ID
- MST-0557
- Conditions
- Obesity, Insulin Resistance, Fatty Liver
- Keywords
- Non-Alcoholic hepatic steatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- Mar 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Sep 2005 (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 test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We, the researchers at Rockefeller University, hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.
This is a 6 week inpatient study.
Detailed description
The hypothesis will be tested by studying two groups of normal subjects who will receive a defined weight maintenance diet: one group will be given meals twice a day and other group will be given eight meals (snacks) per day. At the beginning of the study period and after 4 weeks following the specified frequency of meals, the study subjects will have their whole body insulin sensitivity and hepatic fat content measured by the euglycemic-hyperinsulinemic clamp and MRI of the liver, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high frequency meals group | Active comparator | Other: high frequency of mealsHigh carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks. |
| twice-a -day meals | Active comparator | Other: twice a day mealshigh carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy individuals
- Age between 18-45 years
- Body mass index (BMI) between 18.5 - 24.9
Key exclusion criteria (14 listed)
- Diabetes mellitus
- Chronic drug treatment for any medical condition like hypertension or hyperlipidemia, hyperthyroidism or taking weight control medications.
- Inability to give informed consent.
- Inability to give contact information including permanent residence or provide evidence of stable living environment for the study period.
- Active weight reduction of more than 7 pounds in the last 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 |
|---|---|---|
| high frequency of mealshigh carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks. | Other | high frequency meals group |
| twice a day mealshigh carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks. | Other | twice-a -day meals |
Primary outcome
We will determine total body insulin sensitivity with the help of the hyperinsulinemic-euglycemic clamp. We will also assess hepatic steatosis by conducting MRI scans on our subjects.
Time frame: days 8,9,11 41 and 42
1 secondary outcome
Weight, waist and hip circumference, fasting glucose and insulin, serum ketones, lipids and lipoproteins including VLDL and apolipoprotien B100, liver function tests, serum adiponectin (marker for insulin resistance), and measures of hunger.
Time frame: days 1-42
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 1 Jun 2012.
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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.
Markus Stoffel, MD, PHD principal investigator
Rockefeller 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 high frequency of meals and twice a day meals in people with Obesity and Insulin Resistance, run by Rockefeller 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 3 inclusion and 14 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 1 Jun 2012. 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?
We will determine total body insulin sensitivity with the help of the hyperinsulinemic-euglycemic clamp. We will also assess hepatic steatosis by conducting MRI scans on our subjects. (time frame: days 8,9,11 41 and 42). 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 1 Jun 2012.