NCT04658875

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

Completed NA Last updated 29 July 2024

What this trial tests

NA trial testing Spirulina maxima supplementation in Overweight and Obesity in 12 participants. Completed in 31 May 2024.

Timeline

17 January 2022

Primary endpoint
1 August 2022

31 May 2024

Quick facts

Lead sponsor	Universidad Autonoma de Baja California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	17 January 2022
Primary completion	1 August 2022
Estimated completion	31 May 2024
Sites	1 location across Mexico

Drugs / interventions tested

• Spirulina maxima supplementation
• Wash-out
• Placebo supplementation
• Isoenergetic diet
• Systematic physical exercise program

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Universidad Autonoma de Baja California — full company profile →

Who can join

60 and older, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of <i>Spirulina maxima</i> Intake and Exercise (SIE) on Metabolic and Fitness Parameters in Sedentary Older Adults with Excessive Body Mass: Study Protocol of a Randomized Controlled Trial.
   Hernández-Lepe MA, Manríquez-Torres JJ, Ramos-Lopez O, Serrano-Medina A, et al · · 2021 · cited 1× · PMID 33567780 · DOI 10.3390/ijerph18041605