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)

NCT04630977 | Unknown DMC

• 1 other identifier: UGreenwich2
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• Fat Mass

  Assessment of the total adipose tissue via Bioelectrical Impedance.

  Through study completion, an average of 1 year.

• Fat-free Mass

  Assessment of the total lean mass via Bioelectrical Impedance.

  Through study completion, an average of 1 year.

• Health Perception questionnaire

  Short Form of 12 questions. Higher scores mean better outcomes (score from 0 to 100).

  6 weeks.

• Pittsburgh Sleep Quality Index

  Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).

  6 weeks.

• Stress Level and Mental Health

  Short Form of 4 questions. Higher scores mean worse outcomes (score from 1 to 5).

  6 weeks.

• Adherence to a Mediterranean Diet (PREDIMED questionnaire)

  Short Form of 4 questions. Higher scores mean better outcomes (score from 1 to 5).

  6 weeks.

• International Physical Activity Questionnaire

  7 questions. Higher scores mean better outcomes (score from 1 to 5).

  6 weeks.

• 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

• 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

• 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

• 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 Outcomes (1)

• Adherence to the treatment (regular training, supplement intake and healthy eating)

  6 weeks

Study Arms (3)

Multi-Ingredient Pre-workout Supplement

EXPERIMENTAL

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.

Dietary Supplement: Multi-ingredient Pre-workout supplement; Other: Progressive Resistance Training; Behavioral: Nutritional Patterns Guideline

Isocaloric Placebo

ACTIVE COMPARATOR

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.

Other: Progressive Resistance Training; Behavioral: Nutritional Patterns Guideline

Control

SHAM COMPARATOR

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.

Other: Progressive Resistance Training; Behavioral: Nutritional Patterns Guideline

Interventions

Multi-ingredient Pre-workout supplement DIETARY_SUPPLEMENT

Every important issue has been detailed before.

Also known as: Preworkout

Multi-Ingredient Pre-workout Supplement

Progressive Resistance Training OTHER

The information about it has been detailed in advance.

Also known as: PRT, RT

Control; Isocaloric Placebo; Multi-Ingredient Pre-workout Supplement

Nutritional Patterns Guideline BEHAVIORAL

This intervention has also been described in advance.

Also known as: Nutrition, Healthy Eating

Control; Isocaloric Placebo; Multi-Ingredient Pre-workout Supplement

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Greenwich: lead
• Ingesport Health Spa Consulting: collaborator

Study Sites (1)

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

London, Avery Hill, London., SE9 2BT, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy; Obesity; Obesity, Abdominal; Weight Loss; Stress, Psychological

Interventions

Nutritional Status; Diet, Healthy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Body Weight Changes; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Diet

Study Officials

• Fernando J Naclerio, Dr

  University of Greenwich

  STUDY DIRECTOR

Central Study Contacts

Joel Puente Fernández, PhD Student

CONTACT

+34626610821; jp2979a@gre.ac.uk

Fernando J Naclerio, Dr

CONTACT

+44 (0)20 8331 8441; F.J.Naclerio@greenwich.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 16, 2020
• Study Start: January 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 28, 2023
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

GB (1)