The effect of oral sachet containing extracts of Garcinia cambogia and Plantago psyllium with capsules containing extract of Green tea and Green coffee on weight of obese and over weight people
The effect of oral sachet containing extracts of Garcinia cambogia and Plantago psyllium with capsules containing extract of Green tea and Green coffee and placebo on weight of over weight and obese people in Beheshti nutrition therapy center
The effect of oral sachet containing extracts of Garcinia cambogia and Plantago psyllium with capsules containing extract of Green tea and Green coffee and placebo on blood lipid level(Cholesterol, Triglyceride and
High and low density lipoprotein), fasting blood glucose, liver enzymes and
high sensitive-Critical Reactive Protein and plasma total antioxidant
Design
Randomized clinical trial, controlled with placebo, parallel, double blind, single central
Settings and conduct
This study is a clinical trial on 82 patients BMI>25, aged 18 to 50 who refers to Kashan Beheshti nutrition therapy center. Individuals based on table of random numbers will be divided to one of the groups received herbal or placebo treatment plus standard treatment for 8 weeks randomly . Herbal drug and placebo are presented in the same package and the physician , patients, researcher and statistical analyst are blind .After analyzing data, codes will be decoded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-50 years old.BMI>25
exclusion criteria: metabolic disorders; nutritional supplements; pregnancy; lactation; thyroid and parathyroid disease.
Intervention groups
Intervention group: Weight loss diet+regular physical activity+ oral sachet containing extracts of Garcinia cambogia and Plantago psyllium half an hour before meals and oral capsules containing extract of Green tea and Green coffee after each meal twice a day.each time1. for 8 weeks
Control group: Weight loss diet+regular physical activity+ oral placebo sachet half an hour before meals and placebo capsules after each meal twice a day.each time1. for 8 weeks
Main outcome variables
At the end of study: changes of weight؛ blood Cholesterol؛Triglyceride؛ high and low density lipoprotein؛ fasting blood glucose؛ liver enzymes؛ high sensitive-Critical Reactive Protein and plasma total antioxidant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012438N25
Registration date:2018-02-26, 1396/12/07
Registration timing:registered_while_recruiting
Last update:2018-02-26, 1396/12/07
Update count:0
Registration date
2018-02-26, 1396/12/07
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral sachet containing extracts of Garcinia cambogia and Plantago psyllium with capsules containing extract of Green tea and Green coffee on weight of obese and over weight people
Public title
The effect of oral sachet containing extracts of Garcinia cambogia and Plantago psyllium with capsules containing extract of Green tea and Green coffee on obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-50 years old
BMI>25
Exclusion criteria:
metabolic disorders
nutritional supplements
pregnancy and lactation
thyroid and parathyroid disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized based on table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Coding and similar packaging. The physician, patient, researcher and statistical analyzer are blind. At the end of the study and analysis of data, codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.28
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight changes in people with BMI greater than 25.
Timepoint
At the beginning of the study, the end of the fourth week, the end of the study
Method of measurement
digital scale
2
Description
lipid profile (Cholesterol, Triglyceride and High and low density lipoprotein)
Timepoint
Baseline and End-of-trial
Method of measurement
fasting blood sample
3
Description
fasting blood glucose
Timepoint
Baseline and End-of-trial
Method of measurement
fasting blood sample
4
Description
liver enzymes
Timepoint
Baseline and End-of-trial
Method of measurement
blood sample
5
Description
high sensitive-Critical Reactive Protein
Timepoint
Baseline and End-of-trial
Method of measurement
blood sample
6
Description
plasma total antioxidant
Timepoint
Baseline and End-of-trial
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Weight loss diet+regular physical activity+ oral sachet containing extracts of Garcinia cambogia and Plantago psyllium half an hour before meals and oral capsules containing extract of Green tea and Green coffee after each meal twice a day.each time1. for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Weight loss diet+regular physical activity+ oral placebo sachet half an hour before meals and placebo capsules after each meal twice a day.each time1. for 8 weeks