ObesityPACERNCT02562209
High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER) and Weight Loss
A study testing PACER Diet and Standard weight reducing diet in people with Obesity, run by Diabetes Foundation, India at 1 site in India.
Trial summary
This study evaluates the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- PACER Diet and Standard weight reducing diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Nov 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 25 to 60 years
- Body mass index (BMI) ≥ 25 kg/m2 to 40 kg/m2
- Subjects who have stable weight, i.e. who have not had more than ± 3 kg variation in their weight level in the 3 months prior to screening for this study.
- Absence of significant disease or clinically significant medical history or physical examination during screening in the view of the investigator.
- Subjects willing to provide written inform consent to participate in the study.
Who cannot join
- Body mass index (BMI) > 40 kg/m2
- Any patient taking/requiring drugs known to effect insulin resistance, lipids, vascular reactivity, during the intervention period would be excluded from the study
- Patients on any drugs that change the weight or in conditions where dietary protein supplementation is contraindicated
- Subjects who are consuming a high protein diet on randomization, to be excluded
- Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc
- Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs
Show all 12Show fewer
- Pregnancy \& lactation
- Patients having diagnosed with any of the following:
- Type 2 diabetes mellitus
- Cushing's disease
- Severe end organ damage
- Unwillingness to give written informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Fortis Flt Lt Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: To Determine the Effect of PACER Diet (High Protein Atkin's Complete VEgetaRian Diet) in Obese Subjects
This study evaluates the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.
Read the detailed description
Increasing the protein consumption promotes weight loss through several mechanisms. Diets high in protein promote energy expenditure through increased postprandial thermogenesis, increase total daily expenditure and increase satiety as compared to carbohydrate. The present study aims to evaluate the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.
- Conditions
- Obesity
- Being tested
- PACER Diet, Standard weight reducing diet
- Keywords
- Obesity, Abdominal adiposity, 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.
PACER DietDietary supplement
Pacer diet to be followed for 8 weeks
Standard weight reducing dietOther
Standard weight reducing diet to be followed for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| PACER diet | Experimental | High Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER Diet) to be followed for 8 weeks. Receives: Dietary Supplement: PACER Diet |
| Standard weight reducing diet | Active comparator | This group was prescribed Standard weight reducing diet to be followed for 8 weeks. Receives: Other: Standard weight reducing diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss (kg)
Measured: 8 weeks
Secondary outcomes (2)
Lipid profile
Measured: 8 weeks
Insulin resistance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Anoop Misra, MD, Principal investigator, Diabetes Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562209
- Sponsor's protocol ID
- PACER_2015
- Acronym
- PACER
- Status last verified
- Sep 2015
- First submitted
- 26 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhardwaj S, Misra A. Obesity, diabetes and the Asian phenotype. World Rev Nutr Diet. 2015;111:116-22. doi: 10.1159/000362308. Epub 2014 Nov 17. No abstract available.
PubMed 25418400Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Greaves KA, Paul G, Singer W. The effect of a plant-based low-carbohydrate ("Eco-Atkins") diet on body weight and blood lipid concentrations in hyperlipidemic subjects. Arch Intern Med. 2009 Jun 8;169(11):1046-54. doi: 10.1001/archinternmed.2009.115.
PubMed 19506174
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Effect of PACER Diet (High Protein Atkin's Complete VEgetaRian Diet) in Obese Subjects
- ClinicalTrials.gov ID
- NCT02562209
- Acronym / sponsor ID
- PACER / PACER_2015
- Conditions
- Obesity
- Keywords
- Obesity, Abdominal adiposity, High protein diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Sep 2015 (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 study evaluates the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.
Detailed description
Increasing the protein consumption promotes weight loss through several mechanisms. Diets high in protein promote energy expenditure through increased postprandial thermogenesis, increase total daily expenditure and increase satiety as compared to carbohydrate. The present study aims to evaluate the effects "High Protein Atkin's Complete (lacto) VEgetaRian Diet (Acronym; 'PACER' diet) on weight, body composition and metabolic profiles in obese Asian Indians subjects living in north India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACER diet | Experimental | Dietary Supplement: PACER DietHigh Protein Atkin's Complete (Lacto) VEgetaRian Diet (PACER Diet) to be followed for 8 weeks. |
| Standard weight reducing diet | Active comparator | Other: Standard weight reducing dietThis group was prescribed Standard weight reducing diet to be followed for 8 weeks. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 25 to 60 years
- Body mass index (BMI) ≥ 25 kg/m2 to 40 kg/m2
- Subjects who have stable weight, i.e. who have not had more than ± 3 kg variation in their weight level in the 3 months prior to screening for this study.
- Absence of significant disease or clinically significant medical history or physical examination during screening in the view of the investigator.
- Subjects willing to provide written inform consent to participate in the study.
Key exclusion criteria (12 listed)
- Body mass index (BMI) > 40 kg/m2
- Any patient taking/requiring drugs known to effect insulin resistance, lipids, vascular reactivity, during the intervention period would be excluded from the study
- Patients on any drugs that change the weight or in conditions where dietary protein supplementation is contraindicated
- Subjects who are consuming a high protein diet on randomization, to be excluded
- Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc
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 |
|---|---|---|
| PACER DietPacer diet to be followed for 8 weeks | Dietary supplement | PACER diet |
| Standard weight reducing dietStandard weight reducing diet to be followed for 8 weeks | Other | Standard weight reducing diet |
Primary outcome
Weight loss (kg)
Time frame: 8 weeks
2 secondary outcomes
Lipid profile
Time frame: 8 weeks
Insulin resistance
Time frame: 8 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 29 Sep 2015.
- Background: PubMed 25418400Bhardwaj S, Misra A. Obesity, diabetes and the Asian phenotype. World Rev Nutr Diet. 2015;111:116-22. doi: 10.1159/000362308. Epub 2014 Nov 17. No abstract available.
- Background: PubMed 19506174Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Greaves KA, Paul G, Singer W. The effect of a plant-based low-carbohydrate ("Eco-Atkins") diet on body weight and blood lipid concentrations in hyperlipidemic subjects. Arch Intern Med. 2009 Jun 8;169(11):1046-54. doi: 10.1001/archinternmed.2009.115.
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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.
Anoop Misra, MD principal investigator
Diabetes Foundation, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACER Diet and Standard weight reducing diet in people with Obesity, run by Diabetes Foundation, India at 1 site in India.
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 5 inclusion and 12 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 29 Sep 2015. 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 India. 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?
Weight loss (kg) (time frame: 8 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 NCT02562209, which also lists 2 linked publications.
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 29 Sep 2015.