ObesityNCT01312740
Effects of Two Hypocaloric Diets on Weight Loss
A study testing LC-P-LGI diet and LC-CONV in people with Obesity, run by Ceprodi S.A. Kot at 1 site in France.
Trial summary
The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- LC-P-LGI diet and LC-CONV
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Jul 2008
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 26 to 35 Kg/m2
- 25 to 60 years old
- non diabetic subjects
Who cannot join
- SGOT and SGPT >2.5x the normal
- plasma glucose more than 1.26 g/l
- hepatic or renal or cardiac failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers
The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.
Read the detailed description
The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks. Before the start of the study, all subjects were instructed to maintain their usual lifestyle during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and inflammatory markers were evaluated before and after each dietary period.Body fat and fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the fasting state.
- Conditions
- Obesity
- Being tested
- LC-P-LGI diet, LC-CONV
- Keywords
- obesity, dietary treatment, high protein diet, Low glycaemic index, adipocytes, fat mass, systemic inflammatory markers, improvement of complications, effect on weight loss
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC-P-LGI dietOther
a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.
LC-CONVOther
4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMay 2007
- Primary completionDec 2007
- Study completionJul 2008
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceprodi S.A. Kot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Pierre and Marie Curie University, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312740
- Sponsor's protocol ID
- RCB: 2007-A00329-44
- Status last verified
- Mar 2011
- First submitted
- 9 Mar 2011
- Last updated
- 11 Mar 2011
- Results posted
- No
Publications
Rizkalla SW, Prifti E, Cotillard A, Pelloux V, Rouault C, Allouche R, Laromiguiere M, Kong L, Darakhshan F, Massiera F, Clement K. Differential effects of macronutrient content in 2 energy-restricted diets on cardiovascular risk factors and adipose tissue cell size in moderately obese individuals: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):49-63. doi: 10.3945/ajcn.111.017277. Epub 2011 Dec 14.
PubMed 22170375
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT01312740
- Acronym / sponsor ID
- RCB: 2007-A00329-44
- Conditions
- Obesity
- Keywords
- obesity, dietary treatment, high protein diet, Low glycaemic index, adipocytes, fat mass, systemic inflammatory markers, improvement of complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ceprodi S.A. KotIndustry (pharma, biotech, devices)
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Pierre and Marie Curie University, Assistance Publique - Hôpitaux de Paris
- Study start
- May 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Mar 2011 (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 investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.
Detailed description
The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks. Before the start of the study, all subjects were instructed to maintain their usual lifestyle during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and inflammatory markers were evaluated before and after each dietary period.Body fat and fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the fasting state.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 26 to 35 Kg/m2
- 25 to 60 years old
- non diabetic subjects
Key exclusion criteria (3 listed)
- SGOT and SGPT >2.5x the normal
- plasma glucose more than 1.26 g/l
- hepatic or renal or cardiac failure
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 |
|---|---|---|
| LC-P-LGI dieta hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content. | Other | – |
| LC-CONV4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates). | Other | – |
Primary outcome
Not reported in the source record.
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 11 Mar 2011.
- Derived from this study: PubMed 22170375Rizkalla SW, Prifti E, Cotillard A, Pelloux V, Rouault C, Allouche R, Laromiguiere M, Kong L, Darakhshan F, Massiera F, Clement K. Differential effects of macronutrient content in 2 energy-restricted diets on cardiovascular risk factors and adipose tissue cell size in moderately obese individuals: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):49-63. doi: 10.3945/ajcn.111.017277. Epub 2011 Dec 14.
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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 LC-P-LGI diet and LC-CONV in people with Obesity, run by Ceprodi S.A. Kot at 1 site in France.
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 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 11 Mar 2011. 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 France. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312740, 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 11 Mar 2011.