Effects of Spirulina Supplementation on Overweight or Obese Adults

NCT02993627 | Completed DMC

• 1 other identifier: IR.SBMU.nnftri.Rec.1395.63
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

In this double-blind Randomized Controlled Clinical Trial investigators are going to study the effects of Spirulina supplementation on anthropometric measurements, lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese adults.

Conditions

Obesity

Keywords

obesity; BMI; body weight

Outcome Measures

Primary Outcomes (8)

• body weight

  body weight with minimum of clothes and without shoes through a calibrated scale and with the precision of 100gr

  week 12

• BMI

  calculation

  week 12

• waist circumference

  measuring with an inflexible tapeline with the precision of 0.1cm

  week 12

• hip circumference

  measuring with an inflexible tapeline with the precision of 0.1cm

  week 12

• waist/hip ratio

  calculation

  week 12

• body fat mass

  bioempedance

  week 12

• body fat free mass

  bioempedance

  week 12

• apetite

  questionaire

  week 12

Secondary Outcomes (12)

• serum triaylglycerol

  week 12

• serum total cholesterol

  week 12

• e serum HDL-C

  week 12

• serum LDL-C

  week 12

• serum LDL-C/HDL-C

  week 12

Study Arms (2)

Spirulina

EXPERIMENTAL

daily intake of spirulina tablets weight reduction diet therapy

Dietary Supplement: Spirulina; Other: diet therapy

placebo

PLACEBO COMPARATOR

daily intake of placebo tablets weight reduction diet therapy

Other: diet therapy

Interventions

Spirulina DIETARY_SUPPLEMENT

2 g(4\* 500 mg tablets) daily intake of Spirulina Platensis

Also known as: Spiruvit

Spirulina

diet therapy OTHER

low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat

Also known as: weight reduction diet

Spirulina; placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI\>25 kg/m2
• No history of medications for obesity, diabetes, dyslipidemia, inflammatory disease within 3 months before the study
• No history of vitamin or antioxidant supplementation within 3 months before the study
• Giving written informed consent for participation

You may not qualify if:

• Having chronic kidney or hepatic disease except NAFLD
• Havig hypo or hyperthyroidism
• Having autoimmune and infectious disease
• weight reduction diet therapy within 6 month from the intervention
• Having more than 3kg weight change in recent 2 months
• Having recent surgery
• Taking anticoagulant drugs

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Clinical Nutrition and Diet Therapy Clinic of Shahid Beheshti University of Medical Sciences

Tehran, 1981619573, Iran

Location

Related Publications (6)

• Torres-Duran PV, Ferreira-Hermosillo A, Juarez-Oropeza MA. Antihyperlipemic and antihypertensive effects of Spirulina maxima in an open sample of Mexican population: a preliminary report. Lipids Health Dis. 2007 Nov 26;6:33. doi: 10.1186/1476-511X-6-33.

  PMID: 18039384 RESULT

• Park HJ, Lee YJ, Ryu HK, Kim MH, Chung HW, Kim WY. A randomized double-blind, placebo-controlled study to establish the effects of spirulina in elderly Koreans. Ann Nutr Metab. 2008;52(4):322-8. doi: 10.1159/000151486. Epub 2008 Aug 19.

  PMID: 18714150 RESULT

• Parikh P, Mani U, Iyer U. Role of Spirulina in the Control of Glycemia and Lipidemia in Type 2 Diabetes Mellitus. J Med Food. 2001 Winter;4(4):193-199. doi: 10.1089/10966200152744463.

  PMID: 12639401 RESULT

• Miczke A, Szulinska M, Hansdorfer-Korzon R, Kregielska-Narozna M, Suliburska J, Walkowiak J, Bogdanski P. Effects of spirulina consumption on body weight, blood pressure, and endothelial function in overweight hypertensive Caucasians: a double-blind, placebo-controlled, randomized trial. Eur Rev Med Pharmacol Sci. 2016;20(1):150-6.

  PMID: 26813468 RESULT

• Mazokopakis EE, Papadomanolaki MG, Fousteris AA, Kotsiris DA, Lampadakis IM, Ganotakis ES. The hepatoprotective and hypolipidemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population with non-alcoholic fatty liver disease: a prospective pilot study. Ann Gastroenterol. 2014;27(4):387-394.

  PMID: 25331487 RESULT

• Lee EH, Park JE, Choi YJ, Huh KB, Kim WY. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients. Nutr Res Pract. 2008 Winter;2(4):295-300. doi: 10.4162/nrp.2008.2.4.295. Epub 2008 Dec 31.

  PMID: 20016733 RESULT

MeSH Terms

Conditions

Obesity; Body Weight

Interventions

Diet Therapy; Diet, Reducing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Atoosa Saidpour

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nutrition Science

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)