ObesityPhase 2BALANCENCT00619008
Energy Balance Weight Regulation Study
A Phase 2 study testing Ad libitum low carbohydrate diet, Ad libitum High Complex Carbohydrate Diet and Energy-restricted high complex carbohydrate diet in people with Obesity, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet. 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?
- Ad libitum low carbohydrate diet, Ad libitum High Complex Carbohydrate Diet and Energy-restricted high complex carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Sep 2008
- Phase
- Phase 2
- 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 21-65 years
- Relative good health
Who cannot join
- Major debilitating mental of physical illness that would interfere with participation
- Renal or hepatic disease, diabetes, gallbladder disease, untreated hyper-or hypothyroidism, poorly controlled hypertension (>3 HT medications)
- Use of lipid lowering medications
- Current of recent (within 12 mo) pregnancy or lactation
- Current excessive use of alcohol
- Current/recent (within 1 year)use of tobacco products
- Food allergies, food restrictions, or food preferences that are inconsistent with the research diets
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97229
About this study
Official title: Energy and Appetite Regulation by High and Low CHO Diets
The purpose of this study is to test the hypothesis that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet.
Read the detailed description
The rising epidemic of obesity in the United States is accompanied by widespread public use of low carbohydrate diets for weight loss. The popularity of these diets is due partly to the promise of a "metabolic advantage" that promotes faster weight loss without an overriding sense of hunger. If this claim is true, we hypothesize that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet. To test this hypothesis, we will conduct a randomized, controlled feeding trial in which obese adults will be randomly assigned to one of three interventions: a low-carbohydrate-ad libitum diet, a high-carbohydrate-ad libitum diet, or a high-carbohydrate-energy-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. Participants will eat a standardized weight maintenance diet for 3 weeks. Then, for 6-weeks, participants assigned to either ad libitum group will be given their assigned diet at 120% of there estimated energy needs to maintain weight and allowed to eat as much as desired. Participants assigned to the energy-restricted group will be provided a DASH diet at 67% of their estimated energy needs to maintain weight and asked to eat all foods provided. Food intake will be measured daily. Body weight and hunger and satiety scores will be measured three times a week. Body composition and energy expenditure will be measured before and after the intervention. 24-hour profiles of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1) will be measured before, and on first and last days of the intervention, to compare acute and chronic metabolic effects of the diets. The analysis of primary outcomes will be based on repeated measures and longitudinal models methodology. This study offers a unique opportunity to explore how extreme differences in dietary composition, before and after weight loss, affect components of energy balance and markers of central appetite and weight regulation. These results will be used to design hypothesis-driven studies of the identified mediators of appetite and weight regulation in response to dietary manipulation.
- Conditions
- Obesity
- Being tested
- Ad libitum low carbohydrate diet, Ad libitum High Complex Carbohydrate Diet, Energy-restricted high complex carbohydrate diet
- Keywords
- obesity, low carbohydrate diet, high complex carbohydrate diet, weight regulation hormones, hunger, satiety, energy expenditure, body composition, weight loss
- 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.
Ad libitum low carbohydrate dietOther
Also called Low Carb diet
6 week ad libitum low carbohydrate diet
Ad libitum High Complex Carbohydrate DietOther
Also called DASH diet
6 week ad libitum high complex carbohydrate diet
Energy-restricted high complex carbohydrate dietOther
Also called Energy-restricted DASH diet
6 week energy-restricted (68% of estimated energy requirement for weight maintenance) high complex carbohydrate diet.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ad libitum low carbohydrate diet Receives: Other: Ad libitum low carbohydrate diet |
| 2 | Experimental | Ad libitum high complex carbohydrate diet Receives: Other: Ad libitum High Complex Carbohydrate Diet |
| 3 | Experimental | Energy-restricted high complex carbohydrate diet Receives: Other: Energy-restricted high complex carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour profiles and AUCs of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1).
Measured: Week 2, week 3 and week 9 of intervention
Secondary outcomes (1)
Energy intake, hunger and satiety ratings
Measured: week 2, 3, and 9 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startApr 2005
- Primary completionSep 2008
- Study completionSep 2008
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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Diane D Stadler, PhD, Principal investigator, OSHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619008
- Sponsor's protocol ID
- R21AT002753
- Acronym
- BALANCE
- Status last verified
- Oct 2008
- First submitted
- 15 Feb 2008
- Last updated
- 3 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy and Appetite Regulation by High and Low CHO Diets
- ClinicalTrials.gov ID
- NCT00619008
- Acronym / sponsor ID
- BALANCE / R21AT002753
- Conditions
- Obesity
- Keywords
- obesity, low carbohydrate diet, high complex carbohydrate diet, weight regulation hormones, hunger, satiety, energy expenditure, body composition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Apr 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Feb 2008 (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 hypothesis that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet.
Detailed description
The rising epidemic of obesity in the United States is accompanied by widespread public use of low carbohydrate diets for weight loss. The popularity of these diets is due partly to the promise of a "metabolic advantage" that promotes faster weight loss without an overriding sense of hunger. If this claim is true, we hypothesize that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet. To test this hypothesis, we will conduct a randomized, controlled feeding trial in which obese adults will be randomly assigned to one of three interventions: a low-carbohydrate-ad libitum diet, a high-carbohydrate-ad libitum diet, or a high-carbohydrate-energy-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. Participants will eat a standardized weight maintenance diet for 3 weeks. Then, for 6-weeks, participants assigned to either ad libitum group will be given their assigned diet at 120% of there estimated energy needs to maintain weight and allowed to eat as much as desired. Participants assigned to the energy-restricted group will be provided a DASH diet at 67% of their estimated energy needs to maintain weight and asked to eat all foods provided. Food intake will be measured daily. Body weight and hunger and satiety scores will be measured three times a week. Body composition and energy expenditure will be measured before and after the intervention. 24-hour profiles of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1) will be measured before, and on first and last days of the intervention, to compare acute and chronic metabolic effects of the diets. The analysis of primary outcomes will be based on repeated measures and longitudinal models methodology. This study offers a unique opportunity to explore how extreme differences in dietary composition, before and after weight loss, affect components of energy balance and markers of central appetite and weight regulation. These results will be used to design hypothesis-driven studies of the identified mediators of appetite and weight regulation in response to dietary manipulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Ad libitum low carbohydrate dietAd libitum low carbohydrate diet |
| 2 | Experimental | Other: Ad libitum High Complex Carbohydrate DietAd libitum high complex carbohydrate diet |
| 3 | Experimental | Other: Energy-restricted high complex carbohydrate dietEnergy-restricted high complex carbohydrate diet |
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 21-65 years
- Relative good health
Key exclusion criteria (7 listed)
- Major debilitating mental of physical illness that would interfere with participation
- Renal or hepatic disease, diabetes, gallbladder disease, untreated hyper-or hypothyroidism, poorly controlled hypertension (>3 HT medications)
- Use of lipid lowering medications
- Current of recent (within 12 mo) pregnancy or lactation
- Current excessive use of alcohol
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 |
|---|---|---|
| Ad libitum low carbohydrate dietAlso: Low Carb diet6 week ad libitum low carbohydrate diet | Other | 1 |
| Ad libitum High Complex Carbohydrate DietAlso: DASH diet6 week ad libitum high complex carbohydrate diet | Other | 2 |
| Energy-restricted high complex carbohydrate dietAlso: Energy-restricted DASH diet6 week energy-restricted (68% of estimated energy requirement for weight maintenance) high complex carbohydrate diet. | Other | 3 |
Primary outcome
24-hour profiles and AUCs of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1).
Time frame: Week 2, week 3 and week 9 of intervention
1 secondary outcome
Energy intake, hunger and satiety ratings
Time frame: week 2, 3, and 9 of intervention
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 3 Oct 2008.
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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
OSHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad libitum low carbohydrate diet, Ad libitum High Complex Carbohydrate Diet and Energy-restricted high complex carbohydrate diet in people with Obesity, run by National Center for Complementary and Integrative Health (NCCIH) 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 7 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 3 Oct 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
24-hour profiles and AUCs of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1). (time frame: Week 2, week 3 and week 9 of intervention). 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 3 Oct 2008; AzTrials last refreshed its copy on 28 Oct 2026.