Overweight and ObesityPASO dietNCT03608176
Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity
A study testing PASO diet group, Low-fat diet group and Waiting list group in people with Overweight and Obesity, run by Universidad de Sonora at 1 site in Mexico.
Trial summary
The accumulation of excess of body weight is one of the most important problems worldwide, thus effective and accessible treatments are required. Some authors highlighted that treatment is focused solely on lifestyle (diet, physical activity, behavioral therapy) has a limited effect on body weight because it does not… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- PASO diet group, Low-fat diet group and Waiting list group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 10 Oct 2018to 31 Jul 2021
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mexican adults (> 20 years and <55)
- Residents of the city of Hermosillo, Sonora
- Obesity (BMI> 25 and <45)
- Availability of time to participate in the study.
- Economic capacity to acquire the assigned diet
- Grant informed consent
- Keep a dietary record for one week prior to the intervention
Who cannot join
- Medical conditions that constitute a contraindication for the intervention, such as de-controlled diabetes, dyslipidemia with pharmacological treatment, blood pressure ≥160 / 100 mmHg, heart failure, renal failure, etc.
- Previous bariatric surgery
- Participate in another intervention or treatment for the management of obesity
- Use of drugs or substances with an effect on weight, for example, metformin, orlistat or corticoids
- Weight loss> 5% of total body weight in the last 4 months
- Pregnancy or lactation
Show all 12Show fewer
- Another member of the family or acquaintance who has agreed to participate in the study
- Consumption of more than 10 alcoholic drinks per week
- Use of addictive substances as drugs of abuse
- Psychiatric condition that prevents adherence to treatment, such as severe depression, bipolarity and schizophrenia Illiteracy
- Gastrointestinal problems or any condition where coffee, tea or cinnamon are not well tolerated or contraindicated
- People who drink more than 4 cups of coffee (tea) per day or its equivalent in caffeinated beverages.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro de Promoción de Salud Nutricional (CPSN)
Hermosillo, Sonora, 83000
Rolando Giovanni Díaz Zavala, Ph.D., 6622893793 ext. 4632, giovanni.diaz@unison.mx
Rolando Giovanni Díaz Zavala, Ph.D.
About this study
Official title: Evaluation of the Efficacy of Plant-based Approaches to Stop Obesity Diet in Comparison With a Control Group on Body Weight in Mexican Adults With Overweight and Obesity: Randomized Controlled Trial
The accumulation of excess of body weight is one of the most important problems worldwide, thus effective and accessible treatments are required. Some authors highlighted that treatment is focused solely on lifestyle (diet, physical activity, behavioral therapy) has a limited effect on body weight because it does not consider the biological mechanisms linked to weight loss in patients with obesity. On the other hand, drugs and bariatric surgery consider these biological approaches; however, its costs, safety and effectiveness limits its use on a large scale. Research studies support the existence of compounds in plants (such as epigallocatechin gallate, caffeine, cinnamaldehyde, fiber), and water with biological properties that would contribute to the treatment of overweight and obesity. However, at the moment, these compounds have only been evaluated individually and their effects have been significant but limited clinically, therefore, more research studies are needed to evaluate whether several of these compounds contained in common plants synergistically have a clinical impact on the management of overweight and obesity. The present work integrates diverse plant-based approaches to stop obesity and it is compared with a control group and a waiting list group. The main aim is to evaluate the efficacy of the Plant-based Approaches to Stop Obesity diet (PASO diet) compared with a control group on body weight at 3 months in Mexican adults with overweight and obesity. This is a pilot study designed as a randomized controlled trial. The study will be conducted with a (n=36). The primary outcome is the change in body weight from baseline to 3 months. Secondary outcomes will be the changes from baseline to 3 months in body mass index, waist circumference, systolic and diastolic blood pressure, symptoms of depression, quality of life scales and biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL-cholesterol, triglycerides and gamma glutamyl transferase). Additionally two 24-hour dietary recall will be measured at baseline and 3 months to evaluate adherence to the intervention.
- Conditions
- Overweight and Obesity
- Being tested
- PASO diet group, Low-fat diet group, Waiting list group
- Keywords
- Obesity, Randomized Controlled Trial, Lifestyle Intervention, Plants, Water, Weight loss, Diet, Overweight
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASO diet groupOther
This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol. They will also be instructed to consume green tea (2 cups/day for 3 days/week), black tea (2 cups/day for 2 days/week), coffee (2 cups/day for 2 days/week), cinnamon (1 tsp/day for at least 3 days/week), psyllium fiber (3 tsp/day/week) and water (1.5 L/day/week).
Low-fat diet groupOther
This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol.
Waiting list groupOther
This group will only receive written information with recommendations on healthy eating. When the study finished, this group will receive a behavioral change protocol with a low-fat, low calorie diet.
| Study group | Role | What they receive |
|---|---|---|
| PASO diet group | Experimental | Not described Receives: Other: PASO diet group |
| Low-fat diet group | Active comparator | Not described Receives: Other: Low-fat diet group |
| Waiting list group | Other | Not described Receives: Other: Waiting list group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: baseline to 3 months
Secondary outcomes (11)
Change in waist circumference
Measured: baseline to 3 months
Change in body fat percentage
Measured: baseline to 3 months
Change in the Beck Depression Inventory score
The Beck Depression Inventory (BDI) is a 21-item questionnaire that assesses mood over the previous week. Total scores range from 0 to 63, with higher values indicating greater symptoms of depression. Scores of 0-9 reflect minimal (subclinical) symptoms, values of 10-18, 19-29, and ≥30 indicate mild, moderate, and severe symptoms of depression, respectively.
Measured: baseline to 3 months
Change in the Short Form-36 Health Survey score
The SF-36 Health Survey evaluates aspects of the quality of life in adult populations (over 16 years of age). The result of its application is the generation of eight concepts or scales of health, result of the average of the sum of the questions contained in the questionnaire for each concept. These concepts are: physical function, physical role, corporal pain, general health, vitality, social function, emotional role and mental health. The SF-36 is a self-applied instrument and contains 36 questions. For each scale, the answers to each question are coded and recoded (10 questions), and the results are interpreted on a scale of 0 to 100, lower results indicate poorer health and greater result better health).
Measured: baseline to 3 months
Change in systolic and diastolic blood pressure
Measured: baseline to 3 months
Change in fasting glucose
Measured: baseline to 3 months
Change in total cholesterol
Measured: baseline to 3 months
Change in LDL-cholesterol
Measured: baseline to 3 months
Change in HDL-cholesterol
Measured: baseline to 3 months
Change in triglycerides
Measured: baseline to 3 months
Change in gamma glutamyl transferase
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start10 Oct 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
- Investigators
- Rolando G Díaz Zavala, Ph.D., Principal investigator, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608176
- Sponsor's protocol ID
- PASOdiet-OBMEX-2018
- Acronym
- PASO diet
- Status last verified
- Apr 2020
- First submitted
- 23 Jul 2018
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Plant-based Approaches to Stop Obesity Diet in Comparison With a Control Group on Body Weight in Mexican Adults With Overweight and Obesity: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03608176
- Acronym / sponsor ID
- PASO diet / PASOdiet-OBMEX-2018
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Randomized Controlled Trial, Lifestyle Intervention, Plants, Water, Weight loss, Diet, Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad de SonoraUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 31 Jul 2018 (actual)
- 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 accumulation of excess of body weight is one of the most important problems worldwide, thus effective and accessible treatments are required. Some authors highlighted that treatment is focused solely on lifestyle (diet, physical activity, behavioral therapy) has a limited effect on body weight because it does not consider the biological mechanisms linked to weight loss in patients with obesity. On the other hand, drugs and bariatric surgery consider these biological approaches; however, its costs, safety and effectiveness limits its use on a large scale. Research studies support the existence of compounds in plants (such as epigallocatechin gallate, caffeine, cinnamaldehyde, fiber), and water with biological properties that would contribute to the treatment of overweight and obesity. However, at the moment, these compounds have only been evaluated individually and their effects have been significant but limited clinically, therefore, more research studies are needed to evaluate whether several of these compounds contained in common plants synergistically have a clinical impact on the management of overweight and obesity. The present work integrates diverse plant-based approaches to stop obesity and it is compared with a control group and a waiting list group. The main aim is to evaluate the efficacy of the Plant-based Approaches to Stop Obesity diet (PASO diet) compared with a control group on body weight at 3 months in Mexican adults with overweight and obesity. This is a pilot study designed as a randomized controlled trial. The study will be conducted with a (n=36). The primary outcome is the change in body weight from baseline to 3 months. Secondary outcomes will be the changes from baseline to 3 months in body mass index, waist circumference, systolic and diastolic blood pressure, symptoms of depression, quality of life scales and biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL-cholesterol, triglycerides and gamma glutamyl transferase). Additionally two 24-hour dietary recall will be measured at baseline and 3 months to evaluate adherence to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PASO diet group | Experimental | Other: PASO diet group |
| Low-fat diet group | Active comparator | Other: Low-fat diet group |
| Waiting list group | Other | Other: Waiting list group |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Mexican adults (> 20 years and <55)
- Residents of the city of Hermosillo, Sonora
- Obesity (BMI> 25 and <45)
- Availability of time to participate in the study.
- Economic capacity to acquire the assigned diet
Key exclusion criteria (12 listed)
- Medical conditions that constitute a contraindication for the intervention, such as de-controlled diabetes, dyslipidemia with pharmacological treatment, blood pressure ≥160 / 100 mmHg, heart failure, renal failure, etc.
- Previous bariatric surgery
- Participate in another intervention or treatment for the management of obesity
- Use of drugs or substances with an effect on weight, for example, metformin, orlistat or corticoids
- Weight loss> 5% of total body weight in the last 4 months
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 |
|---|---|---|
| PASO diet groupThis group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol. They will also be instructed to consume green tea (2 cups/day for 3 days/week), black tea (2 cups/day for 2 days/week), coffee (2 cups/day for 2 days/week), cinnamon (1 tsp/day for at least 3 days/week), psyllium fiber (3 tsp/day/week) and water (1.5 L/day/week). | Other | PASO diet group |
| Low-fat diet groupThis group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol. | Other | Low-fat diet group |
| Waiting list groupThis group will only receive written information with recommendations on healthy eating. When the study finished, this group will receive a behavioral change protocol with a low-fat, low calorie diet. | Other | Waiting list group |
Primary outcome
Change in body weight
Time frame: baseline to 3 months
11 secondary outcomes
Change in waist circumference
Time frame: baseline to 3 months
Change in body fat percentage
Time frame: baseline to 3 months
Change in the Beck Depression Inventory score
Time frame: baseline to 3 months
Change in the Short Form-36 Health Survey score
Time frame: baseline to 3 months
Change in systolic and diastolic blood pressure
Time frame: baseline to 3 months
Change in fasting glucose
Time frame: baseline to 3 months
Change in total cholesterol
Time frame: baseline to 3 months
Change in LDL-cholesterol
Time frame: baseline to 3 months
Change in HDL-cholesterol
Time frame: baseline to 3 months
Change in triglycerides
Time frame: baseline to 3 months
Change in gamma glutamyl transferase
Time frame: baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Rolando G Díaz Zavala, Ph.D. principal investigator
Universidad de Sonora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASO diet group, Low-fat diet group and Waiting list group in people with Overweight and Obesity, run by Universidad de Sonora at 1 site in Mexico.
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 7 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: status not confirmed, as of the sponsor's last update on 15 Apr 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolando G Díaz Zavala, Ph.D. (6622893793 ext. 4632, giovanni.diaz@unison.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: baseline to 3 months). 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 15 Apr 2020.