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Effects of Spirulina supplementation on anthropometric measurements, blood lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in overweight or obese adults

Protocol summary

Summary
Objective: assessing the effects of Spirulina supplementation on anthropometric measurements, blood lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in overweight or obese adults. Study design: in this double-blind Randomized Controlled Clinical Trial, Participants will be allocated to Spirulina or Placebo group through Blocked Randomization. Study population: obese and overweight subjects visiting nutrition clinic of Shahid Beheshti University of Medical Sciences. Sample size: fifteen subjects. Intervention: subjects in Spirulina group will consume 2 g Spirulina daily (four tablets of 500mg), whereas the control group receive placebo tablets during 12 weeks of intervention. In addition, subjects receive weight reduction diet during the study period. Outcome measures: anthropometric measurements (body weight, waist and hip circumference, BMI, body composition), inflammatory markers (hs- CRP and adiponectin), glycemic markers (fasting blood glucose and HOMA-IR), lipid profile (triacylglyceride, total cholesterol, LDL-C, HDL-C, LDL-C/HDL-C), liver enzymes (SGOT and SGPT) and appetite.

General information

Acronym
BMI: Body Mass Index, HOMA-IR: Homeostatic Model Assessment- Insulin Resistance, hs- CRP: High sensi
IRCT registration information
IRCT registration number: IRCT2016101615968N4
Registration date: 2017-01-04, 1395/10/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-04, 1395/10/15
Registrant information
Name
Atoosa Saidpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of nutrition
Country
Iran (Islamic Republic of)
Phone
-
Email address
a.saidpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition department of Shahid Beheshti University of Medical sciences
Expected recruitment start date
2014-11-06, 1393/08/15
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Spirulina supplementation on anthropometric measurements, blood lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in overweight or obese adults
Public title
Effects of Spirulina supplementation on obese patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 20-60 years old, 40 kg/m2 >BMI>25 kg/m2, no history of medications for obesity, diabetes, dyslipidemia, inflammatory diseases and vitamin supplementation within 3 months before the study Exclusion criteria: having chronic kidney or hepatic disease except NAFLD, hypo or hyperthyroidism, autoimmune and infectious disease, weight reduction diet therapy within 6 month, more than 3 kg weight change in recent 2 months and recent surgery, taking anticoagulant medications the same as warfarin or aspirin, pregnancy and lactation
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In order to run a double- blind survey, in the beginning the bottle of Spirulina and placebo tablets were labeled as A or B by someone other than the researchers. So, both researchers and patients will be unaware of the type of received tablets.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical sciences
Street address
No. 7, Hafezi (Arghavan) St., Farahzadi Ave., Shahrake Ghods(Gharb) town, Tehran, Iran
City
Tehran
Postal code
1981619573
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.sbmu.nnftri.Rec.1395.63

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E-66, E-65
ICD-10 code description
Obesity, Localized adiposity

Primary outcomes

1

Description
Body weight
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
seca scale

2

Description
BMI
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention
Method of measurement
calculation (kg/m2)

3

Description
waist circumference
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
metere

4

Description
Hip circumference
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
metere

5

Description
waist/hip
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
calculation

6

Description
Body fat mass
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
Bioelectrical impedance analysis (BIA) device

7

Description
Body fat free mass
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
Bioelectrical impedance analysis (BIA) device

8

Description
Appetite
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
simple appetite questionnaire

9

Description
Serum adiponectin
Timepoint
Before intervention and after 12 weeks of intervention
Method of measurement
ELISA

10

Description
Serum hs-CRP
Timepoint
Before intervention and after 12 weeks of intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
serum triacylglycerol
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

2

Description
serum total cholesterol
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

3

Description
HDL-C
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

4

Description
LDL-C
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

5

Description
LDL-C/HDL-C
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
calculation

6

Description
srum glucose
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

7

Description
serum insulin
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
ELISA

8

Description
HOMA-IR
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
calculation ([Glucose]*[Insulin]/405(Glucose in mg/dl))

9

Description
serum SGOT
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

10

Description
serum SGPT
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

Intervention groups

1

Description
Intervention1: Daily intake of 2 g Spirulina as 4 tablets of 5oo mg for 3 months, weight reduction diet therapy simultaneously with Spirulina supplements for 12 weeks
Category
Treatment - Drugs

2

Description
Intervention 2: Daily intake of 4 placebo tablets for 12 weeks, weight reduction diet therapy concurrently with receiving placebo for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhaneh Yousefi
Street address
Baran St.,Hafezi (Arghavan) Ave., Farahzadi Blvd., Ghods (Gharb) twon, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Nasrabadi
Street address
No. 7, Hafezi (Arghavan) st., Farahzdi Blvd., Ghods (Gharb) twon, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Ashbal Chemi Co.
Full name of responsible person
Maryam Soheili
Street address
Third floor, Abiasa bulding, Barforooshan St., Iranshahr Av., Tehran
City
Tehran
Grant name
تأمین کننده قرص های اسپیرولینا برای مطالعه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ashbal Chemi Co.
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
National Institute of Nutrition and Food Technology
Full name of responsible person
Rehaneh Yousefi
Position
MSc. student of Nutrition
Other areas of specialty/work
Street address
No. 7, Hafezi (Arghavan) St., Farahzadi Blvd., Ghods (Gharb) twon, tehran, Iran
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
+98 22360660
Email
yousefi.ryhn@gmail.cominfo@nnftri.ac.ir
Web page address
www.nnftri.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical sciences- School of Nutrition
Full name of responsible person
Atoosa Saidpour
Position
PHD of Nutrition
Other areas of specialty/work
Street address
NO. 7, Hafezi (Arghavan) St., Farahzadi Blvd, Ghods (Gharb) twon, Tehran
City
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
+98 22360660
Email
atoosa.saidpour@gmail.com; info@nnftri.ac.ir
Web page address
www.nnftri.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
National Institute of Nutrition and Food Technology
Full name of responsible person
Reyhaneh Yousefi
Position
MSc. student of Nutrition
Other areas of specialty/work
Street address
NO. 7, Hafezi (Arghavan) St., Farahzadi Blvd, Ghods (Gharb) twon, Tehran
City
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
+98 22360660
Email
yousefi.ryhn@gmail.com; info@nnftri.ac.ir
Web page address
www.nnftri.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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