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)

Not Applicable

• Conditions: Weight Loss; Happiness; Self-Perception; Stress, Psychological; Muscle Loss; Obesity; Obesity, Abdominal; Quality of Life
• Interventions: Dietary Supplement: Multi-ingredient Pre-workout supplement; Other: Progressive Resistance Training; Behavioral: Nutritional Patterns Guideline

• Registration Number: NCT04630977
• Lead Sponsor: University of Greenwich

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-08
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15
• Study Start: 2023-01-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-Ingredient Pre-workout Supplement	Multi-ingredient Pre-workout supplement	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.
Isocaloric Placebo	Progressive Resistance Training	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.
Control	Progressive Resistance Training	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.
Multi-Ingredient Pre-workout Supplement	Progressive Resistance Training	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.
Control	Nutritional Patterns Guideline	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.
Isocaloric Placebo	Nutritional Patterns Guideline	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.
Multi-Ingredient Pre-workout Supplement	Nutritional Patterns Guideline	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.

Primary Outcome Measures

Name	Time	Method
Fat-free Mass	Through study completion, an average of 1 year.	Assessment of the total lean mass via Bioelectrical Impedance.
Upper-Body push strength	6 Weeks	Number of push-ups in 15 seconds.; The score will be the number of Push-Ups performed (higher scores mean better outcomes).
Health Perception questionnaire	6 weeks.	Short Form of 12 questions.; Higher scores mean better outcomes (score from 0 to 100).
Pittsburgh Sleep Quality Index	6 weeks.	Short Form of 4 questions.; Higher scores mean better outcomes (score from 1 to 5).
Lower-body mechanical power	6 Weeks	Jump height with countermovement.; The jump will be performed from a standing position, lateral to the wall and jumping to touch the wall as high as possible (with chalk in their finger-prints to mark the height they touched the wall).; The score will be the height of the jump (higher scores mean better outcomes).
Fat Mass	Through study completion, an average of 1 year.	Assessment of the total adipose tissue via Bioelectrical Impedance.
Stress Level and Mental Health	6 weeks.	Short Form of 4 questions.; Higher scores mean worse outcomes (score from 1 to 5).
Adherence to a Mediterranean Diet (PREDIMED questionnaire)	6 weeks.	Short Form of 4 questions.; Higher scores mean better outcomes (score from 1 to 5).
International Physical Activity Questionnaire	6 weeks.	7 questions.; Higher scores mean better outcomes (score from 1 to 5).
Recovery	6 Weeks	Static running in 1m2 square as fast as possible for 30 seconds and immediately after, Heart Rate will be monitored for 1 minute; The score will be the difference from the Maximum Heart Rate minus the Heart Rate after 1 minute recovery (higher scores mean better outcomes).
Single-Leg balance	6 Weeks	Standing in one leg only, be capable of holding the position for 15 seconds. Performed with the dominant leg at first and the non-dominant leg afterwards.; Score from 1 to 15 (higher scores mean better outcomes).

Secondary Outcome Measures

Name	Time	Method
Adherence to the treatment (regular training, supplement intake and healthy eating)	6 weeks	The compliance with the training and supplementation protocols will be measured constantly, as well as the healthy eating patterns. Those participants who have spent 7 days or more in a row without training or taking the supplement, as well as a final accomplishment of the 85% will be discarded from the final analysis.

Trial Locations

Locations (1)

University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT; 🇬🇧 London, Avery Hill, London., United Kingdom