HealthyDietitian IINCT01115075
Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days
A study testing Dietary fat/intake of carbohydrate and Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake. in people with Healthy, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to understand the mechanisms for oscillations of dietary fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over interval of 3 to 4 days. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary fat/intake of carbohydrate and Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- You are a dietitian or a senior level or graduate level dietetics student
- You are between the ages of 21-55 years inclusive and a nonsmoker
- you are not a restrictive diet or strenuous exercise regimen
- You typically eat several meals per day
Who cannot join
- You have an eating disorder or history
- You abuse alcohol or other substances, and consume no more than 3 alcoholic drinks per day
- You have no current regular use of some over-the-counter medication or prescription medication, excluding headache medicines, blood pressure medications, etc.
- You have gained/lost more than 10 pounds of body weight in the last year
- You have recently had or anticipating significant life changes during the course of your participation in the study.
- You have an eating disorder or history
- You have a major psychiatric illness or history
- You have no serious current clinical disease or surgical condition that may interfere with the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II
The purpose of this study is to understand the mechanisms for oscillations of dietary fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over interval of 3 to 4 days.
Read the detailed description
You will be expected to keep diet records for 17 consecutive days. You will start with a fasting screening visit (only water allowed). A physical exam and Medical history it taken at screening visit. Your body composition will be gathered by CT and Dexa Scan. Blood and urine will be collected for a chemical profile and other determinations. Questionnaires will be administered along with an accelerometer to be worn for the remainder of the study. The final day you will return the dietary records, accelerometer, and a few procedures will be performed as weight.
- Conditions
- Healthy
- Being tested
- Dietary fat/intake of carbohydrate, Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.
- Keywords
- Leptin, Changes in leptin may precede the, phasing of oscillations of dietary fat intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fat/intake of carbohydrateOther
Also called Dietitian II
Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.
Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.Behavioural
Dietitians and senior level or graduate level dietetics students who are not restrained eaters to participate in food intake over 17 days. During this same time interval, integrated energy expenditure will be recorded using doubly-labeled water and day to day energy expenditure by accelerometer. Periodic blood sampling for leptin will be done completed at site intervals.
| Study group | Role | What they receive |
|---|---|---|
| Dietitian | Experimental | Recruitment of dietitians and senior level or graduate level dietetics students who are not restrained eaters. This group is skilled in identifying and accurately recording food than individuals not trained in dietetics. Receives: Other: Dietary fat/intake of carbohydrate; Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanisms for oscillations of dietary fat/carbohydrate intake
Test the spontaneous intake of fat, carbohydrate,protein and alcohol each day for 17 consecutive days. Examine spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.
Measured: 17 consecutive days (11 visits on site)
Secondary outcomes (1)
Energy Intake
During the same time interval, integrated energy expenditure will be recoreded using doubly-labeled water and day to day energy expenditure by accelerometer.
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George A. Bray, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115075
- Sponsor's protocol ID
- PBRC 29017
- Acronym
- Dietitian II
- Status last verified
- Jan 2016
- First submitted
- 14 Apr 2010
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II
- ClinicalTrials.gov ID
- NCT01115075
- Acronym / sponsor ID
- Dietitian II / PBRC 29017
- Conditions
- Healthy
- Keywords
- Leptin, Changes in leptin may precede the, phasing of oscillations of dietary fat intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 May 2010 (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 understand the mechanisms for oscillations of dietary fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over interval of 3 to 4 days.
Detailed description
You will be expected to keep diet records for 17 consecutive days. You will start with a fasting screening visit (only water allowed). A physical exam and Medical history it taken at screening visit. Your body composition will be gathered by CT and Dexa Scan. Blood and urine will be collected for a chemical profile and other determinations. Questionnaires will be administered along with an accelerometer to be worn for the remainder of the study. The final day you will return the dietary records, accelerometer, and a few procedures will be performed as weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietitian | Experimental | Other: Dietary fat/intake of carbohydrate, Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.Recruitment of dietitians and senior level or graduate level dietetics students who are not restrained eaters. This group is skilled in identifying and accurately recording food than individuals not trained in dietetics. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- You are a dietitian or a senior level or graduate level dietetics student
- You are between the ages of 21-55 years inclusive and a nonsmoker
- you are not a restrictive diet or strenuous exercise regimen
- You typically eat several meals per day
Key exclusion criteria (8 listed)
- You have an eating disorder or history
- You abuse alcohol or other substances, and consume no more than 3 alcoholic drinks per day
- You have no current regular use of some over-the-counter medication or prescription medication, excluding headache medicines, blood pressure medications, etc.
- You have gained/lost more than 10 pounds of body weight in the last year
- You have recently had or anticipating significant life changes during the course of your participation in 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 |
|---|---|---|
| Dietary fat/intake of carbohydrateAlso: Dietitian IISpontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days. | Other | Dietitian |
| Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.Dietitians and senior level or graduate level dietetics students who are not restrained eaters to participate in food intake over 17 days. During this same time interval, integrated energy expenditure will be recorded using doubly-labeled water and day to day energy expenditure by accelerometer. Periodic blood sampling for leptin will be done completed at site intervals. | Behavioural | Dietitian |
Primary outcome
Mechanisms for oscillations of dietary fat/carbohydrate intake
Time frame: 17 consecutive days (11 visits on site)
Test the spontaneous intake of fat, carbohydrate,protein and alcohol each day for 17 consecutive days. Examine spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.
1 secondary outcome
Energy Intake
Time frame: 17 days
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 25 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fat/intake of carbohydrate and Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake. in people with Healthy, run by Pennington Biomedical Research Center 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 4 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 25 Jan 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?
Mechanisms for oscillations of dietary fat/carbohydrate intake (time frame: 17 consecutive days (11 visits on site)). 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 25 Jan 2016.