Effect of Spirulina Maxima and Exercise on General Fitness and Blood Lipids in Older Adults

Overweight and Obesity Clinical Trial

Official title:

Effect of a Systematic Physical Exercise Program and Spirulina Maxima Supplementation on the Body Composition, Physical Function and Blood Lipid Profile in Sedentary Older Adults With Excess Weight

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658875
• Other study ID #: 998/2020-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2020
• Source: Universidad Autonoma de Baja California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The global older adult population has grown more than any other age group, which could be explained by the decrease of birth rate and increase of life expectancy. The healthy life expectancy of older adult in Mexico is 65.8 years, and the population's life expectancy in general is 74.4 years, this means that the population meeting that age is at increased risk of developing some disease or dependence during approximately nine years of their life. For the population over 60 years, the three most frequent health conditions reported were hypertension (40%), diabetes (24.3%), and hypercholesterolemia (20.4%). In this sense, the search for a healthy lifestyle is necessary, which includes a healthy diet that includes supplementation with nutraceuticals and the daily practice of physical activity.

Regarding nutraceutical supplementation, the cyanobacterium Spirulina maxima (S. maxima) is an important source of proteins, carotenoids, phenolic compounds and polyunsaturated fatty acids which have been tested for diverse biological activities such as lipid lowering effects, however, existing studies of effects of S. maxima on body composition, physical function and blood lipid profile in humans, mainly in older adults, have a low level of evidence and absence of adequate experimental designs, so its value as a nutraceutical cannot be assured.

The effects of performing systematic physical exercise in older adults have been shown to have positive effects on body composition and blood lipid profile, so in the present study it is proposed to evaluate the synergy presented by a supplement such as S. maxima in a systematic physical exercise program on the body composition, physical function and blood lipid profile of sedentary older adults with excess weight in a randomized, double-blind, crossover, placebo controlled trial.

Description:

According to international estimations, there will be an increase in the aging population worldwide; with projections of a growth in the population older than 60 years from 900 million in 2015 to two billion in 2050. This means that the older population will move from 12% to 22% of the global population. In Mexico, in the year 2000, people aged 60 and older represented 6.8% of the total population, and an increase of 28% was expected by the year 2050; and only in Baja California State, there were 183,577 inhabitants 65 yr. old and older (Men = 46.3%, Women = 53.7%). Data from a census in Baja California's cities of Mexicali and Tijuana municipalities in 2015, showed the highest cluster of older adults above 65 yr., especially women. In Tijuana, there were 78,019 inhabitants over 65 years; with a projected population by 2020 of 101,574, and 176,134 inhabitants by 2030. The healthy life expectancy of the Mexican older adult is 65.8 years. This means that if the population's life expectancy in general is 74.4 years, the population meeting that age is at increased risk of developing some disease or dependence during approximately nine years of their life. For the population over 60 years, the three most frequent health conditions reported were hypertension (40.0%), diabetes (24.3%) and hypercholesterolemia (20.4%). These diseases affect all body systems and prevent them from carrying out daily life activities such as walking, eating, preparing or buying food, and bathing, among others. In this sense, the search for a healthy lifestyle is necessary, which includes a healthy diet that includes supplementation with nutraceuticals and the daily practice of physical activity.

Regarding supplementation with nutraceuticals, the cyanobacterium S. maxima is an important source of antioxidants, currently associated with cardiovascular protection properties. For centuries it has been cultivated and used as a nutritional supplement due to its content of amino acids and essential fatty acids, vitamin C, vitamin E, carotenoids and phycocyanins. Recently, studies on S. maxima have focused on verifying the biological activity of its components, including hypolipidemic effects. However, most studies have been conducted in animal models, with only a few studies focused on the biological effect in humans. However, most studies have been conducted in animal models, with scarce studies focused on its effects on humans. Previous researches have shown smaller adipose depots, lower blood lipid concentrations, and lower body mass gain in mice administered with a high-fat diet and S. maxima than in an high-fat diet mice control. Some studies have found a decrease in body mass, waist circumference, plasma lipid levels, inflammation, and oxidative stress in hypertensive obese patients with S. maxima supplementation (2 g for three months). However, controlled studies focused on the effect of the administration of S. maxima and a systematic exercise program in humans, have not yet been reported.

Studies on the potential effects of nutraceutical supplements are increasing in number. There have been reported the effect of 2 g/day of S. maxima supplementation on 40 hypertension subjects in a double-blind, placebo-controlled randomized trial for three months. After the intervention, they reported a significant reduction of body weight, BMI, and blood pressure in the group supplemented with S. maxima, compared with that of the placebo group. Some investigators studied the effect of Spirulina supplementation (1 g/day) during three months on the body weight, BMI, and lipid profile in patients with dyslipidemia and reported a significant decrease in total cholesterol (TC), triglycerides (TG), and cholesterol associated with low-density lipoproteins (LDL-C).

Some Spirulina compounds can reduce the macrophages infiltration into visceral fat and prevent the accumulation of liver lipids, resulting in weight reduction, specifically body fat, and there has been proved the effect of Spirulina supplementation (2 g/day) during two months on the serum lipid profile of 15 patients affected by type II diabetes mellitus, resulting in a significant reduction of TG, TC, LDL-C, and free fatty acid in blood concentrations. By means of a better-structured trial.

Many of the beneficial effects of Spirulina are attributed to its nutritional content, but its action mechanisms are poorly understood. Some authors suggest that a possible component responsible of the S. maxima hypolipidemic effect is C-phycocyanin protein, which improves the blood lipid profile. Some authors suggest that C-phycocyanin increases endogenous enzymes activity, scavenging free radicals, and downregulates cofactors in fat metabolism like adenine dinucleotide phosphate. Spirulina hypolipidemic effects can be attributed to the fact that dietary supplementation with the cyanobacteria seems to have decreased the intestinal assimilation of cholesterol, probably because Spirulina compounds bind to bile acids in the jejunum, affecting the micellar solubility of cholesterol before suppressing the cholesterol absorption. However, these studies were conducted in animal models and therefore their results cannot be extrapolated to humans, and clinical studies conducted in humans are still very scarce and appropriate clinical trials are needed to elucidate this.

Furthermore, it is known that the practice of systematic physical exercise ameliorates the risk of hypertension, diabetes and hypercholesterolemia, physical exercise of moderate intensity has the best protective effect, mainly due to physiological adaptations. Exercise has been also included as part of multicomponent interventions targeting physical function in socioeconomically vulnerable older adults in rural communities. Korean older adults (n= 187) performed a 24-week program that included group exercise, nutritional supplementation and depression management, among other components. Physical function and depression were measured before and after the intervention, with significant improvements following the intervention. Thus, appropriate exercise programs need to be implemented.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: October 31, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Sedentary older adults

• BMI over 25 kg/m2

• Volunteered to participate

Exclusion Criteria:

• Presenting a chronical disease

• Drinking alcohol

• Taking diet supplements

• Presenting an impediment to practicing regular physical exercise

Elimination Criteria:

• Attendance by the subject of < 80% to the physical exercise sessions

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Spirulina maxima supplementation
Supplementation with Spirulina maxima (4.5 g/d) in capsules during 12 weeks.

Other:
• Wash-out
2 weeks washout period to each study subject to avoid any possible carryover effect.
• Placebo supplementation
Supplementation with placebo (4.5 g/d) in capsules during 12 weeks.
• Isoenergetic diet
All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 26 weeks
• Systematic physical exercise program
Participants in the systematic physical exercise program groups will exercise for five days a week. The physical activity program will consist of Monday to Friday chair exercises performed during 24 weeks. The approximate exercise duration will be 40 to 50 min. Each exercise session has an initial or warm-up phase (~ 10 min), a main physical conditioning phase (~ 25 min), and a cool-down or relaxation phase (~ 10 min). The physical activities to select have a metabolic equivalent tasks (METs) considered as moderate, between 3.0 and 6.0 METs. Trained personnel will assist older adults to perform the activities, including articular flexibility using elastic bands, postural and proprioception exercises with materials such as rubber balls, wood sticks, and small sandbags. These activities will be selected according to the deterioration and joint stiffness that the participants could present.

Locations

Country	Name	City	State
Mexico	Medical and Psychology School	Tijuana	California

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California

Country where clinical trial is conducted

Mexico, 

References & Publications (24)

Boardley D, Fahlman M, Topp R, Morgan AL, McNevin N. The impact of exercise training on blood lipids in older adults. Am J Geriatr Cardiol. 2007 Jan-Feb;16(1):30-5. — View Citation

Chamorro G, Salazar M, Favila L, Bourges H. [Pharmacology and toxicology of Spirulina alga]. Rev Invest Clin. 1996 Sep-Oct;48(5):389-99. Spanish. — View Citation

Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25. Erratum in: N Engl J Med. 2014 Feb 27;370(9):886. Corrected and republished in: N Engl J Med. 2018 Jun 21;378(25):e34. Retraction in: N Engl J Med. 2018 Jun 21;378(25):2441-2442. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. — View Citation

Fenster CP, Weinsier RL, Darley-Usmar VM, Patel RP. Obesity, aerobic exercise, and vascular disease: the role of oxidant stress. Obes Res. 2002 Sep;10(9):964-8. Review. — View Citation

Fujimoto M, Tsuneyama K, Fujimoto T, Selmi C, Gershwin ME, Shimada Y. Spirulina improves non-alcoholic steatohepatitis, visceral fat macrophage aggregation, and serum leptin in a mouse model of metabolic syndrome. Dig Liver Dis. 2012 Sep;44(9):767-74. doi: 10.1016/j.dld.2012.02.002. Epub 2012 Mar 22. — View Citation

Hernández Lepe MA, Wall-Medrano A, Juárez-Oropeza MA, Ramos-Jiménez A, Hernández-Torres RP. [SPIRULINA AND ITS HYPOLIPIDEMIC AND ANTIOXIDANT EFFECTS IN HUMANS: A SYSTEMATIC REVIEW]. Nutr Hosp. 2015 Aug 1;32(2):494-500. doi: 10.3305/nh.2015.32.2.9100. Review. Spanish. — View Citation

Hosseini SM, Khosravi-Darani K, Mozafari MR. Nutritional and medical applications of spirulina microalgae. Mini Rev Med Chem. 2013 Jun 1;13(8):1231-7. Review. — View Citation

Iwata K, Inayama T, Kato T. Effects of Spirulina platensis on plasma lipoprotein lipase activity in fructose-induced hyperlipidemic rats. J Nutr Sci Vitaminol (Tokyo). 1990 Apr;36(2):165-71. — View Citation

Jang IY, Jung HW, Park H, Lee CK, Yu SS, Lee YS, Lee E, Glynn RJ, Kim DH. A multicomponent frailty intervention for socioeconomically vulnerable older adults: a designed-delay study. Clin Interv Aging. 2018 Sep 19;13:1799-1814. doi: 10.2147/CIA.S177018. eCollection 2018. — View Citation

Kalafati M, Jamurtas AZ, Nikolaidis MG, Paschalis V, Theodorou AA, Sakellariou GK, Koutedakis Y, Kouretas D. Ergogenic and antioxidant effects of spirulina supplementation in humans. Med Sci Sports Exerc. 2010 Jan;42(1):142-51. doi: 10.1249/MSS.0b013e3181ac7a45. — View Citation

Kata FS, Athbi AM, Manwar EQ, Al-Ashoor A, Abdel-Daim MM, Aleya L. Therapeutic effect of the alkaloid extract of the cyanobacterium Spirulina platensis on the lipid profile of hypercholesterolemic male rabbits. Environ Sci Pollut Res Int. 2018 Jul;25(20):19635-19642. doi: 10.1007/s11356-018-2170-4. Epub 2018 May 7. — View Citation

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. — View Citation

Manrique-Espinoza B, Salinas-Rodríguez A, Moreno-Tamayo KM, Acosta-Castillo I, Sosa-Ortiz AL, Gutiérrez-Robledo LM, Téllez-Rojo MM. [Health conditions and functional status of older adults in Mexico]. Salud Publica Mex. 2013;55 Suppl 2:S323-31. Spanish. — View Citation

Mazokopakis EE, Starakis IK, Papadomanolaki MG, Mavroeidi NG, Ganotakis ES. The hypolipidaemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population: a prospective study. J Sci Food Agric. 2014 Feb;94(3):432-7. doi: 10.1002/jsfa.6261. Epub 2013 Jul 10. — View Citation

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. — View Citation

Nagaoka S, Shimizu K, Kaneko H, Shibayama F, Morikawa K, Kanamaru Y, Otsuka A, Hirahashi T, Kato T. A novel protein C-phycocyanin plays a crucial role in the hypocholesterolemic action of Spirulina platensis concentrate in rats. J Nutr. 2005 Oct;135(10):2425-30. — View Citation

Petretto DR, Pili R, Gaviano L, Matos López C, Zuddas C. [Active ageing and success: A brief history of conceptual models]. Rev Esp Geriatr Gerontol. 2016 Jul-Aug;51(4):229-41. doi: 10.1016/j.regg.2015.10.003. Epub 2016 May 2. Review. Spanish. — View Citation

Seo YJ, Kim KJ, Choi J, Koh EJ, Lee BY. Spirulina maxima Extract Reduces Obesity through Suppression of Adipogenesis and Activation of Browning in 3T3-L1 Cells and High-Fat Diet-Induced Obese Mice. Nutrients. 2018 Jun 1;10(6). pii: E712. doi: 10.3390/nu10060712. — View Citation

Serban MC, Sahebkar A, Dragan S, Stoichescu-Hogea G, Ursoniu S, Andrica F, Banach M. A systematic review and meta-analysis of the impact of Spirulina supplementation on plasma lipid concentrations. Clin Nutr. 2016 Aug;35(4):842-51. doi: 10.1016/j.clnu.2015.09.007. Epub 2015 Sep 25. Review. — View Citation

Szulinska M, Gibas-Dorna M, Miller-Kasprzak E, Suliburska J, Miczke A, Walczak-Galezewska M, Stelmach-Mardas M, Walkowiak J, Bogdanski P. Spirulina maxima improves insulin sensitivity, lipid profile, and total antioxidant status in obese patients with well-treated hypertension: a randomized double-blind placebo-controlled study. Eur Rev Med Pharmacol Sci. 2017 May;21(10):2473-2481. — View Citation

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. — View Citation

Ugwuja E, Ogbonna N, Nwibo A, Onimawo Ia. Overweight and Obesity, Lipid Profile and Atherogenic Indices among Civil Servants in Abakaliki, South Eastern Nigeria. Ann Med Health Sci Res. 2013 Jan;3(1):13-8. doi: 10.4103/2141-9248.109462. — View Citation

Upasani CD, Balaraman R. Protective effect of Spirulina on lead induced deleterious changes in the lipid peroxidation and endogenous antioxidants in rats. Phytother Res. 2003 Apr;17(4):330-4. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood lipid profile	Change in plasma triacylglycerols, total cholesterol, high density lipoproteins cholesterol, and low density lipoproteins cholesterol after each treatment by using standardized enzymatic methods.	26 weeks
Primary	Change in body composition	Change in body fat percentage by using air displacement plethysmography and of bioimpedance analysis.	26 weeks
Primary	Changes in functional physical condition	The functional physical condition will be evaluated with the Senior Fitness Test (SFT)	26 weeks
Secondary	Lower-body strength	The lower-body strength (SFT-LBS) will be assessed by the 30 s test of getting up and sitting down from a chair.	26 weeks
Secondary	Changes in upper-body strength	The upper-body strength (SFT-UBS) will be evaluated by the 30 s arm curl with a dumbbell (men = 8-lb, women = 5-lb).	26 weeks
Secondary	Changes in lower-body flexibility	Lower-body flexibility (SFT-LBF) will be assessed by the chair flexion test, where participants slowly flex the hip joint, reaching as much as possible or surpassing the toes.	26 weeks
Secondary	Changes in upper-body flexibility	Upper-body flexibility (SFT-UBF) will be assessed by the hands test behind the back. The distance between the tips of the middle fingers will be assessed independently of the alignment of the back.	26 weeks
Secondary	Changes in agility	Agility will assessed by the 2.44 m timed-up and go test (SFT- TUG), where participants had to get up of a chair, walk as fast as possible 2.44 m and sit down again.	26 weeks
Secondary	Changes in aerobic resistance	Aerobic resistance will be evaluated by the 2-min standing marching test (SFT-marching), where participants had to perform as many repetitions (reps) as possible	26 weeks