Trials / Unknown
UnknownNCT04630977
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)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3,000 (estimated)
- Sponsor
- University of Greenwich · Academic / Other
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Muscle Loss
- Obesity
- Obesity, Abdominal
- Weight Loss
- Happiness
- Quality of Life
- Self-Perception
- Stress, Psychological
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Multi-ingredient Pre-workout supplement | Every important issue has been detailed before. |
| OTHER | Progressive Resistance Training | The information about it has been detailed in advance. |
| BEHAVIORAL | Nutritional Patterns Guideline | This intervention has also been described in advance. |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2023-05-01
- Completion
- 2023-05-28
- First posted
- 2020-11-16
- Last updated
- 2021-12-15
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04630977. Inclusion in this directory is not an endorsement.