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)

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04630977
• Other study ID #: UGreenwich2
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 28, 2023

Study information

• Verified date: December 2021
• Source: University of Greenwich
• Contact: Joel Puente Fernández, PhD Student
• Phone: +34626610821
• Email: jp2979a[@]gre.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: May 28, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Happiness
• Muscle Loss
• Obesity
• Obesity, Abdominal
• Quality of Life
• Self-Perception
• Stress, Psychological
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT	London	Avery Hill, London.

Sponsors (2)

Lead Sponsor	Collaborator
University of Greenwich	Ingesport Health Spa Consulting

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat Mass	Assessment of the total adipose tissue via Bioelectrical Impedance.	Through study completion, an average of 1 year.
Primary	Fat-free Mass	Assessment of the total lean mass via Bioelectrical Impedance.	Through study completion, an average of 1 year.
Primary	Health Perception questionnaire	Short Form of 12 questions.; Higher scores mean better outcomes (score from 0 to 100).	6 weeks.
Primary	Pittsburgh Sleep Quality Index	Short Form of 4 questions.; Higher scores mean better outcomes (score from 1 to 5).	6 weeks.
Primary	Stress Level and Mental Health	Short Form of 4 questions.; Higher scores mean worse outcomes (score from 1 to 5).	6 weeks.
Primary	Adherence to a Mediterranean Diet (PREDIMED questionnaire)	Short Form of 4 questions.; Higher scores mean better outcomes (score from 1 to 5).	6 weeks.
Primary	International Physical Activity Questionnaire	7 questions.; Higher scores mean better outcomes (score from 1 to 5).	6 weeks.
Primary	Single-Leg balance	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).	6 Weeks
Primary	Upper-Body push strength	Number of push-ups in 15 seconds.; The score will be the number of Push-Ups performed (higher scores mean better outcomes).	6 Weeks
Primary	Lower-body mechanical power	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).	6 Weeks
Primary	Recovery	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).	6 Weeks
Secondary	Adherence to the treatment (regular training, supplement intake and healthy eating)	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.	6 weeks