Clinical trial NCT04630977: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Loss
Obesity
Obesity, Abdominal
Weight Loss
Happiness
Quality of Life
Self-Perception
Stress, Psychological
Keywords: Weight Loss
Body Composition
Home-Based
Supplement
Multi-ingredient
Lead sponsor: University of Greenwich
Sponsor class: OTHER
Collaborators: name: Ingesport Health Spa Consulting
First posted: 2020-11-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will intake a pre-workout multi-ingredient supplement. The second group will intake an isocaloric placebo containing only carbohydrates.

The third group (control) will take a non-caloric placebo.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fat Mass
timeFrame: Through study completion, an average of 1 year.
measure: Fat-free Mass
timeFrame: Through study completion, an average of 1 year.
measure: Health Perception questionnaire
timeFrame: 6 weeks.
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 weeks.
measure: Stress Level and Mental Health
timeFrame: 6 weeks.
measure: Adherence to a Mediterranean Diet (PREDIMED questionnaire)
timeFrame: 6 weeks.
measure: International Physical Activity Questionnaire
timeFrame: 6 weeks.
measure: Single-Leg balance
timeFrame: 6 Weeks
measure: Upper-Body push strength
timeFrame: 6 Weeks
measure: Lower-body mechanical power
timeFrame: 6 Weeks
measure: Recovery
timeFrame: 6 Weeks
Secondary outcomes:
measure: Adherence to the treatment (regular training, supplement intake and healthy eating)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
state: Avery Hill, London.
Study officials:
affiliation: University of Greenwich
name: Fernando J Naclerio, Dr
role: STUDY_DIRECTOR
References: