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

NCT04658875 | Completed DMC

• 1 other identifier: 998/2020-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Change in body composition

  Change in body fat percentage by using air displacement plethysmography and of bioimpedance analysis.

  26 weeks

• Changes in functional physical condition

  The functional physical condition will be evaluated with the Senior Fitness Test (SFT)

  26 weeks

Secondary Outcomes (6)

• Lower-body strength

  26 weeks

• Changes in upper-body strength

  26 weeks

• Changes in lower-body flexibility

  26 weeks

• Changes in upper-body flexibility

  26 weeks

• Changes in agility

  26 weeks

Other Outcomes (1)

• Change in blood lipid profile

  26 weeks

Study Arms (4)

Spirulina maxima supplementation and exercise group

EXPERIMENTAL

Supplementation with Spirulina maxima (4.5 g/d) with a systematic physical exercise program during 12 weeks, then a 2 weeks washout, to finally proceed to the other treatment during 12 more weeks. During the 26 weeks of study duration every participant will have a personal isoenergetic diet.

Dietary Supplement: Spirulina maxima supplementation; Other: Wash-out; Other: Isoenergetic diet; Other: Systematic physical exercise program

Spirulina maxima supplementation

EXPERIMENTAL

Supplementation with Spirulina maxima (4.5 g/d) without exercise program during 12 weeks, then a 2 weeks washout, to finally proceed to the other treatment during 12 more weeks. During the 26 weeks of study duration every participant will have a personal isoenergetic diet.

Dietary Supplement: Spirulina maxima supplementation; Other: Wash-out; Other: Isoenergetic diet

Exercise group

EXPERIMENTAL

Systematic physical exercise program during 12 weeks, then a 2 weeks washout, to finally proceed to the other treatment during 12 more weeks. During the 26 weeks of study duration every participant will have a personal isoenergetic diet.

Other: Wash-out; Other: Placebo supplementation; Other: Isoenergetic diet; Other: Systematic physical exercise program

Control group

ACTIVE COMPARATOR

No systematic physical exercise program and No supplementation during 12 weeks, then a 2 weeks washout, to finally proceed to the other treatment during 12 more weeks. During the 26 weeks of study duration every participant will have a personal isoenergetic diet.

Other: Wash-out; Other: Placebo supplementation; Other: Isoenergetic diet

Interventions

Spirulina maxima supplementation DIETARY_SUPPLEMENT

Supplementation with Spirulina maxima (4.5 g/d) in capsules during 12 weeks.

Spirulina maxima supplementation; Spirulina maxima supplementation and exercise group

Wash-out OTHER

2 weeks washout period to each study subject to avoid any possible carryover effect.

Control group; Exercise group; Spirulina maxima supplementation; Spirulina maxima supplementation and exercise group

Placebo supplementation OTHER

Supplementation with placebo (4.5 g/d) in capsules during 12 weeks.

Control group; Exercise group

Isoenergetic diet OTHER

All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 26 weeks

Control group; Exercise group; Spirulina maxima supplementation; Spirulina maxima supplementation and exercise group

Systematic physical exercise program OTHER

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.

Exercise group; Spirulina maxima supplementation and exercise group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sedentary older adults
• BMI over 25 kg/m2
• Volunteered to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Medical and Psychology School

Tijuana, California, 22390, Mexico

Location

Related Publications (25)

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  PMID: 33567780 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants' group allocations will be performed by an independent researcher, who has not any other participation during the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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. This experimental design was chosen to eliminate inter-individual differences related to Spirulina maxima/placebo

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 9, 2020
• Study Start: January 17, 2022
• Primary Completion: August 1, 2022
• Study Completion: May 31, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)