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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)

Primary Purpose

Muscle Loss, Obesity, Obesity, Abdominal

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Multi-ingredient Pre-workout supplement
Progressive Resistance Training
Nutritional Patterns Guideline
Sponsored by
University of Greenwich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Loss focused on measuring Weight Loss, Body Composition, Home-Based, Supplement, Multi-ingredient

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Multi-Ingredient Pre-workout Supplement

Isocaloric Placebo

Control

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Fat Mass
Assessment of the total adipose tissue via Bioelectrical Impedance.
Fat-free Mass
Assessment of the total lean mass via Bioelectrical Impedance.
Health Perception questionnaire
Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100).
Pittsburgh Sleep Quality Index
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
Stress Level and Mental Health
Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5).
Adherence to a Mediterranean Diet (PREDIMED questionnaire)
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
International Physical Activity Questionnaire
7 questions. Higher scores mean better outcomes (score from 1 to 5).
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).
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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
November 8, 2020
Last Updated
December 14, 2021
Sponsor
University of Greenwich
Collaborators
Ingesport Health Spa Consulting
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1. Study Identification

Unique Protocol Identification Number
NCT04630977
Brief 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)
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Greenwich
Collaborators
Ingesport Health Spa Consulting

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Every participant will be randomized to any of the groups. The principal investigator will be blinded for the supplement and allocation of the participants until the end of the analysis of the results after the intervention. Therefore, an external and third researcher will send the supplements to every participant and will keep the record of the randomised allocation of each of them until the end of the analysis of the last outcomes assessments collection.
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-Ingredient Pre-workout Supplement
Arm Type
Experimental
Arm 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.
Arm Title
Isocaloric Placebo
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Multi-ingredient Pre-workout supplement
Other Intervention Name(s)
Preworkout
Intervention Description
Every important issue has been detailed before.
Intervention Type
Other
Intervention Name(s)
Progressive Resistance Training
Other Intervention Name(s)
PRT, RT
Intervention Description
The information about it has been detailed in advance.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Patterns Guideline
Other Intervention Name(s)
Nutrition, Healthy Eating
Intervention Description
This intervention has also been described in advance.
Primary Outcome Measure Information:
Title
Fat Mass
Description
Assessment of the total adipose tissue via Bioelectrical Impedance.
Time Frame
Through study completion, an average of 1 year.
Title
Fat-free Mass
Description
Assessment of the total lean mass via Bioelectrical Impedance.
Time Frame
Through study completion, an average of 1 year.
Title
Health Perception questionnaire
Description
Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100).
Time Frame
6 weeks.
Title
Pittsburgh Sleep Quality Index
Description
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
Time Frame
6 weeks.
Title
Stress Level and Mental Health
Description
Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5).
Time Frame
6 weeks.
Title
Adherence to a Mediterranean Diet (PREDIMED questionnaire)
Description
Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).
Time Frame
6 weeks.
Title
International Physical Activity Questionnaire
Description
7 questions. Higher scores mean better outcomes (score from 1 to 5).
Time Frame
6 weeks.
Title
Single-Leg balance
Description
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).
Time Frame
6 Weeks
Title
Upper-Body push strength
Description
Number of push-ups in 15 seconds. The score will be the number of Push-Ups performed (higher scores mean better outcomes).
Time Frame
6 Weeks
Title
Lower-body mechanical power
Description
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).
Time Frame
6 Weeks
Title
Recovery
Description
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).
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Adherence to the treatment (regular training, supplement intake and healthy eating)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Puente Fernández, PhD Student
Phone
+34626610821
Email
jp2979a@gre.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando J Naclerio, Dr
Phone
+44 (0)20 8331 8441
Email
F.J.Naclerio@greenwich.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando J Naclerio, Dr
Organizational Affiliation
University of Greenwich
Official's Role
Study Director
Facility Information:
Facility Name
University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT
City
London
State/Province
Avery Hill, London.
ZIP/Postal Code
SE9 2BT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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)

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