Long-term Intervention Effects of a Personalized, Home-based Exercise Program and Nutritional Advice, Along With the Inclusion of a Pre-workout Multi-ingredient Supplement on the Body Composition, Functional Capacity and Quality of Life of Middle-aged and Older Adults (40-70 Years)

University of Greenwich

Status: Unknown

Conditions: Weight Loss; Happiness; Obesity, Abdominal; Quality of Life; Obesity; Self-Perception; Muscle Loss; Stress, Psychological

Treatments: Other: Progressive Resistance Training; Dietary Supplement: Multi-ingredient Pre-workout supplement; Behavioral: Nutritional Patterns Guideline

Study type: Interventional

Funder types: Other

Identifiers

NCT04630977

UGreenwich2

Details and patient eligibility

About

The purpose of this study is to analyse the potential benefits of ingesting a commercially available pre-workout multi-ingredient supplement providing ~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine -L-arginine AKG, L-Leucine, Taurine, L-citrulline- 6.8 g, Creatine monohydrate: 2g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg) vs Placebo CHO intake on body composition, physical performance, Happiness Score (specially designed by our sponsor company, including different self-reported and validated tests on their short form) and every workout: Self-perceived energy feeling and adherence to the intervention.

Full description

The methodology will follow a Home-based, online, double-blinded, randomised, long-term design. The participants recruited will be active, middle-aged and older healthy adults. The supplement intake will be a Pre-workout supplement intake or a placebo intake. The exercise training will be a Progressive Resistance Training, with sessions of ~1 hour (3 times/week). The intervention will last for a minimum of one year and the possibility to prolong it to another one (two years of intervention) if the adherence to the treatment was higher to the 75% of the participants (of, at least, 85% of the training sessions and supplementation intake).

The outcomes that will be assessed are: Body composition (fat mass and fat-free mass), physical performance (short test designed by Go Fit Lab: single-leg standing balance, upper-body strength - maximum number of push-ups repetitions in 15 seconds -, lower-body mechanical power - vertical jump -, agility/velocity - 30 seconds of static running at maximum velocity -, recovery assessment - 60 seconds monitoring of heart rate after the previous test -), Happiness Score (designed by Go Fit, including different self-reported validated tests, such as: Par-Q+, ACSM Cardiovascular Risk Factors Questionnaire, SF-12 for quality of life and self-perceived health status, PSS-4 Stress and mental health, Pittsburgh Sleeping Quality test, PREDIMED test: adherence to Mediterranean diet eating patterns, and the IPAQ short form), and for every workout: Self-perceived energy feeling (Questionnaire: Energy Level, Fatigue, Alertness and Focus for the Task), Rate of Perceived Exertion (OMNI RES Scale and Borg Scale) and adherence to regular physical exercise practise, healthy nutritional patterns, and supplement intake.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults (no current injuries or illnesses which may interfere with the project).
• Recreationally active adults (a minimum of 3 and a maximum of 5 days of training sessions per week: combining resistance and endurance).

Exclusion criteria

• Participants younger than 40 or older than 70 years old.
• Participants with hard injuries, disabilities or pathologies.
• People taking medication or other supplements which may interfere with the multi-ingredient pre-workout or the training sessions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,000 participants in 3 patient groups

Multi-Ingredient Pre-workout Supplement

Experimental group

Description:

This group of participants will intake a multi-ingredient supplement around \~15 minutes before every workout. The nutritional information of the supplement is: \~90 Kcal. for 25g of powder: carbohydrates -isomaltulose, fructose, maltodextrin- 15 g, essential amino-acids -Beta-alanine: 2.5g, L-arginine AKG: 2.5g, L-Leucine: 800mg, Taurine: 500mg, L-citrulline: 500mg- 6.8 g, Creatine monohydrate: 2.0g, Guarana Extract: 800mg, total caffeine: 160mg, and Magnesium: 112.5mg. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups.

Treatment:

Behavioral: Nutritional Patterns Guideline

Other: Progressive Resistance Training

Dietary Supplement: Multi-ingredient Pre-workout supplement

Isocaloric Placebo

Active Comparator group

Description:

This group of participants will intake an isocaloric (only carbohydrates: Maltodextrin) supplement comparator, around \~15 minutes before every workout. The nutritional information of the supplement is: \~90 Kcal. for 23g of powder. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups.

Treatment:

Behavioral: Nutritional Patterns Guideline

Other: Progressive Resistance Training

Control

Sham Comparator group

Description:

These participants will drink a non-caloric admixture with the same taste, texture and flavour. They will also follow a previously designed progressive resistance training (3 times a week, around 1 hour a day, consisting of different exercises). Also, they will receive a specific guideline with simple tips to improve their nutritional patterns. The training sessions and the nutritional guideline will be the same for the three groups.

Treatment:

Behavioral: Nutritional Patterns Guideline

Other: Progressive Resistance Training