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Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity (PASO diet)

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ClinicalTrials.gov Identifier: NCT03608176
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Rolando Giovanni Díaz Zavala, Universidad de Sonora

Brief 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 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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Other: PASO diet group Other: Low-fat diet group Other: Waiting list group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: PASO diet group Other: PASO diet group
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).

Active Comparator: Low-fat diet group Other: Low-fat diet group
This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol.

Waiting list group Other: Waiting list group
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.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: baseline to 3 months ]

Secondary Outcome Measures :
  1. Change in waist circumference [ Time Frame: baseline to 3 months ]
  2. Change in body fat percentage [ Time Frame: baseline to 3 months ]
  3. Change in the Beck Depression Inventory score [ Time Frame: baseline to 3 months ]
    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.

  4. Change in the Short Form-36 Health Survey score [ Time Frame: baseline to 3 months ]
    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).

  5. Change in systolic and diastolic blood pressure [ Time Frame: baseline to 3 months ]
  6. Change in fasting glucose [ Time Frame: baseline to 3 months ]
  7. Change in total cholesterol [ Time Frame: baseline to 3 months ]
  8. Change in LDL-cholesterol [ Time Frame: baseline to 3 months ]
  9. Change in HDL-cholesterol [ Time Frame: baseline to 3 months ]
  10. Change in triglycerides [ Time Frame: baseline to 3 months ]
  11. Change in gamma glutamyl transferase [ Time Frame: baseline to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608176


Contacts
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Contact: Rolando G Díaz Zavala, Ph.D. 6622893793 ext 4632 giovanni.diaz@unison.mx

Locations
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Mexico
Centro de Promoción de Salud Nutricional (CPSN) Recruiting
Hermosillo, Sonora, Mexico, 83000
Contact: Rolando Giovanni Díaz Zavala, Ph.D.    6622893793 ext 4632    giovanni.diaz@unison.mx   
Principal Investigator: Rolando Giovanni Díaz Zavala, Ph.D.         
Sponsors and Collaborators
Universidad de Sonora
Investigators
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Principal Investigator: Rolando G Díaz Zavala, Ph.D. Universidad de Sonora

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Responsible Party: Rolando Giovanni Díaz Zavala, Principal Investigator, Universidad de Sonora
ClinicalTrials.gov Identifier: NCT03608176     History of Changes
Other Study ID Numbers: PASOdiet-OBMEX-2018
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rolando Giovanni Díaz Zavala, Universidad de Sonora:
Obesity
Randomized Controlled Trial
Lifestyle Intervention
Plants
Water
Weight loss
Diet
Overweight

Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms