ObesityLOWERNCT00862953
Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study
A study testing Normal protein energy-restricted and High protein energy-restricted in people with Obesity, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Normal protein energy-restricted and High protein energy-restricted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Oct 2010
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obesity with BMI > 27 kg/m2
Who cannot join
- Recent loss of body weight (>10%)
- Underlying malignancy, HIV infection, psychiatric disease
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Lifestyle, OverWeight, Energy Restriction Study
This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.
Read the detailed description
Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.
- Conditions
- Obesity
- Being tested
- Normal protein energy-restricted, High protein energy-restricted
- Keywords
- low carbohydrate, high protein diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal protein energy-restrictedDietary supplement
Normal protein diet energy restricted
High protein energy-restrictedDietary supplement
High protein diet, with either low or normal carbohydrate content
| Study group | Role | What they receive |
|---|---|---|
| Normal protein normal carbohydrate | Active comparator | Normal protein normal carbohydrate calory restricted nutrition Receives: Dietary Supplement: Normal protein energy-restricted |
| Normal protein low carbohydrates | Experimental | Normal protein low carbohydrate energy-restricted diet Receives: Dietary Supplement: Normal protein energy-restricted |
| High protein normal carbohydrates | Experimental | High protein normal carbohydrates Receives: Dietary Supplement: High protein energy-restricted |
| High protein low carbohydrate | Experimental | High protein low carbohydrate nutrition Receives: Dietary Supplement: High protein energy-restricted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionOct 2010
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.
- More trials run by University Medical Center GroningenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- F NR Van Berkum, MD PhD, Study director, Previtas Hengelo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862953
- Sponsor's protocol ID
- BWO08-002
- Acronym
- LOWER
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2009
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lifestyle, OverWeight, Energy Restriction Study
- ClinicalTrials.gov ID
- NCT00862953
- Acronym / sponsor ID
- LOWER / BWO08-002
- Conditions
- Obesity
- Keywords
- low carbohydrate, high protein diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Mar 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.
This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.
Detailed description
Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal protein normal carbohydrate | Active comparator | Dietary Supplement: Normal protein energy-restrictedNormal protein normal carbohydrate calory restricted nutrition |
| Normal protein low carbohydrates | Experimental | Dietary Supplement: Normal protein energy-restrictedNormal protein low carbohydrate energy-restricted diet |
| High protein normal carbohydrates | Experimental | Dietary Supplement: High protein energy-restrictedHigh protein normal carbohydrates |
| High protein low carbohydrate | Experimental | Dietary Supplement: High protein energy-restrictedHigh protein low carbohydrate nutrition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obesity with BMI > 27 kg/m2
Key exclusion criteria (3 listed)
- Recent loss of body weight (>10%)
- Underlying malignancy, HIV infection, psychiatric disease
- Pregnancy or breast feeding
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 |
|---|---|---|
| Normal protein energy-restrictedNormal protein diet energy restricted | Dietary supplement | Normal protein low carbohydrates, Normal protein normal carbohydrate |
| High protein energy-restrictedHigh protein diet, with either low or normal carbohydrate content | Dietary supplement | High protein low carbohydrate, High protein normal carbohydrates |
Primary outcome
Body weight
Time frame: 1 year
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 18 Apr 2024.
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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.
F NR Van Berkum, MD PhD study director
Previtas Hengelo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal protein energy-restricted and High protein energy-restricted in people with Obesity, run by University Medical Center Groningen 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 1 inclusion and 3 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 18 Apr 2024. 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?
Body weight (time frame: 1 year). 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 18 Apr 2024.