ObesityNCT00868387
Macronutrient Relations and Weight Loss in Obese Subjects
A study testing energy-restricted, CHO-restricted diet and energy-restricted, CHO-rich diet in people with Obesity, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- energy-restricted, CHO-restricted diet and energy-restricted, CHO-rich diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2005to Dec 2007
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-70 years
- body mass index > 27 kg/m2
Who cannot join
- history of cardiovascular symptomatology
- cholelithiasis
- urolithiasis
- insulin dependent diabetes
- pacemaker implantation
- pregnancy
- lactation
- vegetarianism
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart Center North Rhine-Westfalia
Bad Oeynhausen, North Rhine-Westfalia, 32545
About this study
Official title: Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program
The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy of weight loss programs depends on care and control. The investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.
Read the detailed description
see brief summary.
- Conditions
- Obesity
- Being tested
- energy-restricted, CHO-restricted diet, energy-restricted, CHO-rich diet
- Keywords
- weight reduction, low-carbohydrate, body fat, telemedicine, cardiovascular risk markers
- 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.
energy-restricted, CHO-restricted dietOther
carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months
energy-restricted, CHO-rich dietOther
carbohydrate content of diet > 55% Frequency: daily Duration: 12 months
| Study group | Role | What they receive |
|---|---|---|
| energy-restricted, CHO-restricted diet | Experimental | Interventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months Receives: Other: energy-restricted, CHO-restricted diet |
| energy-restricted, CHO-rich diet | Active comparator | Comparator: carbohydrate content of diet: > 55% Frequency: daily Duration: 12 months Receives: Other: energy-restricted, CHO-rich diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Measured: 12 months
Secondary outcomes (5)
waist circumference
Measured: 12 months
blood pressure
Measured: 12 months
blood lipids
Measured: 12 months
parameters of glucose metabolism
Measured: 12 months
fat mass
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startNov 2005
- Primary completionNov 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heinrich Koertke, PhD, Principal investigator, Heart Center NRW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868387
- Sponsor's protocol ID
- 003
- Status last verified
- Dec 2013
- First submitted
- 24 Mar 2009
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Frisch S, Zittermann A, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Kortke H. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program. Cardiovasc Diabetol. 2009 Jul 18;8:36. doi: 10.1186/1475-2840-8-36.
PubMed 19615091
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program
- ClinicalTrials.gov ID
- NCT00868387
- Acronym / sponsor ID
- 003
- Conditions
- Obesity
- Keywords
- weight reduction, low-carbohydrate, body fat, telemedicine, cardiovascular risk markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 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.
The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy of weight loss programs depends on care and control. The investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.
Detailed description
see brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| energy-restricted, CHO-restricted diet | Experimental | Other: energy-restricted, CHO-restricted dietInterventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months |
| energy-restricted, CHO-rich diet | Active comparator | Other: energy-restricted, CHO-rich dietComparator: carbohydrate content of diet: > 55% Frequency: daily Duration: 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-70 years
- body mass index > 27 kg/m2
Key exclusion criteria (8 listed)
- history of cardiovascular symptomatology
- cholelithiasis
- urolithiasis
- insulin dependent diabetes
- pacemaker implantation
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 |
|---|---|---|
| energy-restricted, CHO-restricted dietcarbohydrate content of the diet < 40% Frequency: daily Duration: 12 months | Other | energy-restricted, CHO-restricted diet |
| energy-restricted, CHO-rich dietcarbohydrate content of diet > 55% Frequency: daily Duration: 12 months | Other | energy-restricted, CHO-rich diet |
Primary outcome
body weight
Time frame: 12 months
5 secondary outcomes
waist circumference
Time frame: 12 months
blood pressure
Time frame: 12 months
blood lipids
Time frame: 12 months
parameters of glucose metabolism
Time frame: 12 months
fat mass
Time frame: baseline, 12 months
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 22 Mar 2017.
- Results publication: PubMed 19615091Frisch S, Zittermann A, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Kortke H. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program. Cardiovasc Diabetol. 2009 Jul 18;8:36. doi: 10.1186/1475-2840-8-36.
- Individual participant dataSharing planned: No
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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.
Heinrich Koertke, PhD principal investigator
Heart Center NRW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing energy-restricted, CHO-restricted diet and energy-restricted, CHO-rich diet in people with Obesity, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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 2 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 22 Mar 2017. 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 Germany. 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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868387, which also lists 1 linked publication.
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 22 Mar 2017.