ObesityPhase 1EBSNCT01029483
The Energy Balance Study
A Phase 1 study testing Low carbohydrate diet, High-carbohydrate ad libitum intervention and High carbohydrate diet-energy matched intervention in people with Obesity, run by Oregon Health and Science University.
Trial summary
Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular weight-loss methods in the United States. The purpose of the Energy Balance Study is to explore how extreme differences in diet affect eating behaviors, activity and calorie-use, and body composition. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low carbohydrate diet, High-carbohydrate ad libitum intervention and High carbohydrate diet-energy matched intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jun 2009
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI; 30-50 kg/m2
- Age at least 21 years
- Relative good health
Who cannot join
- Major debilitating mental or physical illness that would interfere with participation
- Renal or hepatic disease, diabetes
- History of gallbladder disease/removal
- Hyper-or hypothyroidism
- Poorly controlled hypertension
- Use of lipid lowering medications
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- Pregnancy or lactation
- Current excessive use of alcohol
- Current/recent chronic use of tobacco
About this study
Official title: Energy and Appetite Regulation by Low CHO Diets
Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular weight-loss methods in the United States. The purpose of the Energy Balance Study is to explore how extreme differences in diet affect eating behaviors, activity and calorie-use, and body composition.
We will conduct a controlled feeding study (all food will be provided for the duration of the study) in which obese adults will be randomly assigned to one of three dietary groups: a low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be based on the "Dietary Approaches to Stop Hypertension (DASH)" diet. During the first 3 weeks, participants will eat a typical diet adjusted so that they neither gain or lose weight. Then, for 6 weeks, they will eat their assigned research diet. Resting calorie use and body composition measurements will be taken at the end of week 2 and week 9. Frequent blood sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end of weeks 2 and week 9 and for 12 hours at the end of week 3.
Change in body composition, activity and energy expenditure, and blood components known to influence eating behavior will be measured under typical diet conditions and after one-day and 6 weeks of the research diet.
- Conditions
- Obesity
- Being tested
- Low carbohydrate diet, High-carbohydrate ad libitum intervention, High carbohydrate diet-energy matched intervention
- Keywords
- Obesity, Weight loss, low carbohydrate diets, high complex carbohydrate diets, Healthy adults, Body composition, Energy Expenditure
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietOther
Also called Low CHO diet, Atkins Diet
Ad libitum low carbohydrate diet (<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired.
High-carbohydrate ad libitum interventionOther
Also called High CHO-ad lib diet, DASH-ad lib diet
Participants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired
High carbohydrate diet-energy matched interventionOther
Also called High CHO energy-matched diet, DASH energy-mathched diet
Participants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at ~70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else.
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate diet | Experimental | 6 week ad libitum low carbohydrate diet; research diet provided at 120% of estimated energy requirement for weight maintenance; carbohydrate intake limited to 28g/d Receives: Other: Low carbohydrate diet |
| High Carbohydrate Diet-ad libitum | Active comparator | High complex carbohydrate diet (55% carbohydrate, 18% protein, 27% fat. 120% of estimated energy needs for weight maintenance provided, participants allowed to eat as much or as little as desired to satisfy appetite Receives: Other: High-carbohydrate ad libitum intervention |
| High Carbohydrate Diet-Energy-matched | Active comparator | High carbohydrate diet (55% carbohydrate, 18% protein and 27% fat). Energy intake restricted to ~68% of energy needs for weight maintenance. Participants required to eat all food provided and nothing else Receives: Other: High carbohydrate diet-energy matched intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
weightloss
Measured: 6 weeks
Secondary outcomes (1)
weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startSep 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Investigators
- Diane D Stadler, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029483
- Sponsor's protocol ID
- R21AT002753
- Acronym
- EBS
- Status last verified
- Dec 2009
- First submitted
- 9 Dec 2009
- Last updated
- 10 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy and Appetite Regulation by Low CHO Diets
- ClinicalTrials.gov ID
- NCT01029483
- Acronym / sponsor ID
- EBS / R21AT002753
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, low carbohydrate diets, high complex carbohydrate diets, Healthy adults, Body composition, Energy Expenditure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Dec 2009 (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.
Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular weight-loss methods in the United States. The purpose of the Energy Balance Study is to explore how extreme differences in diet affect eating behaviors, activity and calorie-use, and body composition.
We will conduct a controlled feeding study (all food will be provided for the duration of the study) in which obese adults will be randomly assigned to one of three dietary groups: a low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be based on the "Dietary Approaches to Stop Hypertension (DASH)" diet. During the first 3 weeks, participants will eat a typical diet adjusted so that they neither gain or lose weight. Then, for 6 weeks, they will eat their assigned research diet. Resting calorie use and body composition measurements will be taken at the end of week 2 and week 9. Frequent blood sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end of weeks 2 and week 9 and for 12 hours at the end of week 3.
Change in body composition, activity and energy expenditure, and blood components known to influence eating behavior will be measured under typical diet conditions and after one-day and 6 weeks of the research diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate diet | Experimental | Other: Low carbohydrate diet6 week ad libitum low carbohydrate diet; research diet provided at 120% of estimated energy requirement for weight maintenance; carbohydrate intake limited to 28g/d |
| High Carbohydrate Diet-ad libitum | Active comparator | Other: High-carbohydrate ad libitum interventionHigh complex carbohydrate diet (55% carbohydrate, 18% protein, 27% fat. 120% of estimated energy needs for weight maintenance provided, participants allowed to eat as much or as little as desired to satisfy appetite |
| High Carbohydrate Diet-Energy-matched | Active comparator | Other: High carbohydrate diet-energy matched interventionHigh carbohydrate diet (55% carbohydrate, 18% protein and 27% fat). Energy intake restricted to ~68% of energy needs for weight maintenance. Participants required to eat all food provided and nothing else |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI; 30-50 kg/m2
- Age at least 21 years
- Relative good health
Key exclusion criteria (9 listed)
- Major debilitating mental or physical illness that would interfere with participation
- Renal or hepatic disease, diabetes
- History of gallbladder disease/removal
- Hyper-or hypothyroidism
- Poorly controlled hypertension
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 carbohydrate dietAlso: Low CHO diet, Atkins DietAd libitum low carbohydrate diet (<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired. | Other | Low carbohydrate diet |
| High-carbohydrate ad libitum interventionAlso: High CHO-ad lib diet, DASH-ad lib dietParticipants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired | Other | High Carbohydrate Diet-ad libitum |
| High carbohydrate diet-energy matched interventionAlso: High CHO energy-matched diet, DASH energy-mathched dietParticipants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at ~70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else. | Other | High Carbohydrate Diet-Energy-matched |
Primary outcome
weightloss
Time frame: 6 weeks
1 secondary outcome
weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY)
Time frame: 6 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 10 Dec 2009.
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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.
Diane D Stadler, PhD principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low carbohydrate diet, High-carbohydrate ad libitum intervention and High carbohydrate diet-energy matched intervention in people with Obesity, run by Oregon Health and Science University.
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 9 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 10 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
weightloss (time frame: 6 weeks). 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 10 Dec 2009.