Over WeightPhase 2/3NCT01358890
Low-Carbohydrate Diet Intervention on Body Weight
A Phase 2/3 study testing low carbohydrate diet and Calories restricted diet in people with Over Weight and Obesity, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The primary aim of this study is to determine the adherence of low- carbohydrate among Chinese. Then compare the effect of low-carbohydrate and traditional Chinese but restricted-calories diet on weight loss and metabolic traits. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Over Weight, Obesity
- What is being tested?
- low carbohydrate diet and Calories restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Aug 2011
- Phase
- Phase 2/3
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight/obese (BMI ≥24 kg/m2)
Who cannot join
- Pregnancy or lactation;
- Serum creatinine and blood urea nitrogen level beyond the clinical reference value;
- alanine aminotransferase and aspartate aminotransferase beyond the reference levels;
- Gastrointestinal problems that would prevent them from complying with the specified feeding conditions;
- Received gastrointestinal surgery (except for appendicitis or hernia);
- Severer CVD;
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- Active cancer;
- Mental diseases, epilepsia or using anti-depression drugs;
- Participating in other scientific studies within 3 months before the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight
- The primary aim of this study is to determine the adherence of low- carbohydrate among Chinese.
- Then compare the effect of low-carbohydrate and traditional Chinese but restricted-calories diet on weight loss and metabolic traits.
Read the detailed description
Obesity is a well established risk factor for type 2 diabetes mellitus, hypertension, dyslipidemia and cardiovascular disease. Along with rapid nutritional and lifestyle transition featured as increased energy dense diet intake and reduced physical activity, the prevalence of obesity has reached epidemic level and affected more than 70 million Chinese adults nowadays. Previous studies suggested that low-carbohydrate diet was an effective and safe way to lose weight and had potential benefit on lipids profiles. However, it is still unknown whether this diet can be feasible to control the epidemic of obesity and its related metabolic diseases among Chinese, whose carbohydrate consumption contribute approximately 55% of total energy intake.
Therefore, the aim of this pilot study is to investigate the adherence and effectiveness of two weight-loss diets among Chinese. This will be a randomized, controlled clinical trial. A total of 50 overweight or obese nurse assistants will be randomly assigned to receive a low-carbohydrate diet or a traditional high-carbohydrate Chinese but restricted-calories diet for 12 weeks. The adherence of study protocol and effects of the two diets on body weight, waist circumference, body fat, fasting glucose and lipid profile will be evaluated.
- Conditions
- Over Weight, Obesity
- Being tested
- low carbohydrate diet, Calories restricted diet
- Keywords
- over weight, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low carbohydrate dietOther
Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
Calories restricted dietOther
Total energy intake is restricted to 1200 kcal/day for women. Energy from carbohydrate, protein and fat will be kept to approximate 55%, 20% and 25%, respectively. Moreover, saturated fat and dietary cholesterol are restricted to at most 10% energy and 300 mg/day, respectively
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | Subjects will be supplied with low carbohydrate diet for 12 weeks. Receives: Other: low carbohydrate diet |
| A | Experimental | Subjects will be supplied with calories restricted diet for 12 weeks Receives: Other: Calories restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Measured: 12 weeks
Secondary outcomes (10)
body fat mass
Measured: 12 weeks
waist circumference
Measured: 12 weeks
body mass index
Measured: 12 weeks
fast glucose
Measured: 12 weeks
total cholesterol
Measured: 12 weeks
triglyceride
Measured: 12 weeks
LDL-C
Measured: 12 weeks
HDL-C
Measured: 12 weeks
blood pressure
Measured: 12 weeks
urinary ketone
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
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 Over WeightStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Xu Lin, Chinese Academy of Sciences
- Investigators
- Xu Lin, PhD, Principal investigator, Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358890
- Sponsor's protocol ID
- 30930081/C150502-LC
- Status last verified
- Feb 2012
- First submitted
- 23 May 2011
- Last updated
- 28 Feb 2012
- Results posted
- No
Publications
Ma Y, Sun Y, Sun L, Liu X, Zeng R, Lin X, Li Y. Effects of gut microbiota and fatty acid metabolism on dyslipidemia following weight-loss diets in women: Results from a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5511-5520. doi: 10.1016/j.clnu.2021.09.021. Epub 2021 Sep 23.
PubMed 34656033
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight
- ClinicalTrials.gov ID
- NCT01358890
- Acronym / sponsor ID
- 30930081/C150502-LC
- Conditions
- Over Weight, Obesity
- Keywords
- over weight, obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 May 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 primary aim of this study is to determine the adherence of low- carbohydrate among Chinese.
- Then compare the effect of low-carbohydrate and traditional Chinese but restricted-calories diet on weight loss and metabolic traits.
Detailed description
Obesity is a well established risk factor for type 2 diabetes mellitus, hypertension, dyslipidemia and cardiovascular disease. Along with rapid nutritional and lifestyle transition featured as increased energy dense diet intake and reduced physical activity, the prevalence of obesity has reached epidemic level and affected more than 70 million Chinese adults nowadays. Previous studies suggested that low-carbohydrate diet was an effective and safe way to lose weight and had potential benefit on lipids profiles. However, it is still unknown whether this diet can be feasible to control the epidemic of obesity and its related metabolic diseases among Chinese, whose carbohydrate consumption contribute approximately 55% of total energy intake.
Therefore, the aim of this pilot study is to investigate the adherence and effectiveness of two weight-loss diets among Chinese. This will be a randomized, controlled clinical trial. A total of 50 overweight or obese nurse assistants will be randomly assigned to receive a low-carbohydrate diet or a traditional high-carbohydrate Chinese but restricted-calories diet for 12 weeks. The adherence of study protocol and effects of the two diets on body weight, waist circumference, body fat, fasting glucose and lipid profile will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Other: low carbohydrate dietSubjects will be supplied with low carbohydrate diet for 12 weeks. |
| A | Experimental | Other: Calories restricted dietSubjects will be supplied with calories restricted diet for 12 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight/obese (BMI ≥24 kg/m2)
Key exclusion criteria (9 listed)
- Pregnancy or lactation;
- Serum creatinine and blood urea nitrogen level beyond the clinical reference value;
- alanine aminotransferase and aspartate aminotransferase beyond the reference levels;
- Gastrointestinal problems that would prevent them from complying with the specified feeding conditions;
- Received gastrointestinal surgery (except for appendicitis or hernia);
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 dietDietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day | Other | B |
| Calories restricted dietTotal energy intake is restricted to 1200 kcal/day for women. Energy from carbohydrate, protein and fat will be kept to approximate 55%, 20% and 25%, respectively. Moreover, saturated fat and dietary cholesterol are restricted to at most 10% energy and 300 mg/day, respectively | Other | A |
Primary outcome
weight
Time frame: 12 weeks
10 secondary outcomes
body fat mass
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
body mass index
Time frame: 12 weeks
fast glucose
Time frame: 12 weeks
total cholesterol
Time frame: 12 weeks
triglyceride
Time frame: 12 weeks
LDL-C
Time frame: 12 weeks
HDL-C
Time frame: 12 weeks
blood pressure
Time frame: 12 weeks
urinary ketone
Time frame: 12 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 28 Feb 2012.
- Derived from this study: PubMed 34656033Ma Y, Sun Y, Sun L, Liu X, Zeng R, Lin X, Li Y. Effects of gut microbiota and fatty acid metabolism on dyslipidemia following weight-loss diets in women: Results from a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5511-5520. doi: 10.1016/j.clnu.2021.09.021. Epub 2021 Sep 23.
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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.
Xu Lin, PhD principal investigator
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing low carbohydrate diet and Calories restricted diet in people with Over Weight and Obesity, run by Chinese Academy of Sciences at 1 site in China.
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 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 28 Feb 2012. 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 China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
weight (time frame: 12 weeks). 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 NCT01358890, 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 28 Feb 2012; AzTrials last refreshed its copy on 1 Nov 2026.