Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000071820
Ethics application status
Approved
Date submitted
24/09/2020
Date registered
29/01/2021
Date last updated
29/01/2021
Date data sharing statement initially provided
29/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying health-related body composition changes in adults following strength training combined with a low-calorie diet.
Scientific title
A pilot study to identify the extent and variability of changes in body
composition and metabolic health after accentuated eccentric strength
training combined with a hypocaloric high protein diet in adults.
Secondary ID [1] 302947 0
Nil
Universal Trial Number (UTN)
U1111-1258-5898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 319153 0
Condition category
Condition code
Metabolic and Endocrine 317120 317120 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Only one cohort will be recruited. Although anecdotal reports suggest that responses to accentuated eccentric strength training differ between three broad age-groups of the adult lifespan, there are insufficient published data to calculate three age-group cutoff points. This preliminary study is expected to determine within-subject changes, and whether age-group differences are detectable. From anecdotal experience, we expect our data will at least reveal a trend towards differences in the extent of physiological responses between a young, middle, and older age group.

Specific details of the interventions follow.
Accentuated eccentric strength training
Performed on proprietary equipment (trade name X-Force) designed to safely conduct accentuated eccentric strength training of upper and lower limb and torso muscles.
Procedures consist of a participant "warming up" on a stationary cycle for 5 minutes.
An assigned trainer then guides the participant through a short set of 5 to 8 repetitions to the point of momentary muscular failure (MMF), which is the point at which they cannot complete a full repetition after attempting to contract on the concentric phase for 5s. Each participant will do this on each of the nine X-Force machines. Each machine is designed to exercise a single muscle or functionally similar group during a defined range and extent of movement, e.g., knee extension through 90 degrees, elbow flexion through a full range of movement.
Experienced strength trainers (minimum of 1 year of training members) who specialise in eccentric strength training will be assigned to the study. The frequency of training sessions will be no more than twice per week, each session will take 20-30 minutes.
Training will be conducted in the BodyTech gym located in Nugent St Auckland.
A unique feature of the X-Force machines is that positional settings and initial movement resistance can be adjusted to each individual, thereby minimising undesired forces being applied to joints and muscles. Importantly, the resistance to concentric and eccentric muscle contraction movements is adjusted so that the resistance applied during eccentric contraction is 40% higher than the resistance applied during concentric contraction. Research indicates accentuated eccentric training of muscles improves muscle strength and mass, as well as metabolic measures such as blood pressure, and blood glucose.

Hypocaloric Diet:
During the 8-week training programme, all the participants will be following the same hypocaloric, high protein diet which they will complete at home. Each participant will be given a digital “Clean Eating Plan” eBook which is a complete reduced-calorie diet (hypocaloric diet) designed to work in conjunction with a high-intensity strength training programme. Each participant will be shown how to use the programme and adhere to the diet by one of the Personal Trainers or one of the experimenters (Jessica Cadenhead, Peter Rana, Sarah Peek) at BodyTech Gym. The recipes have been expertly devised by a registered nutritionist and lecturer in nutrition (Nicola Page, Registered Nutritionist) and apply the latest scientific evidence for best nutritional practices and strategies. The Clean Eating Plan consists of easily implemented guidelines to help you create a workable personal eating plan, which includes a week-by-week caloric intake schedule. For females, the daily caloric intake is 1,300kcal/day on a non-workout day and then 1,500kcal/day on the two workout days. For males, the daily caloric intake is 1,500kcal/day on a non-workout day and then 1,700kcal/day on the two workout days. The additional calories on the workout days account for a post-workout protein supplement (protein shake) which is key to this eating plan. The plan also includes how much protein the participant should be consuming based on their ideal weight and age. For those under 40 years old, it is recommended to consume 1.2g/kg of protein per day and for those over 40 years old, it is recommended to consume 1.5g/kg due to the aging effect of utilizing amino acids for muscle building processes. The participants will be asked to complete food diaries for 3 days of each week to ensure they are complying with the diet. Participants will also be asked questions at the beginning of each strength training session by one of the personal trainers regarding diet adherence.
Adherence to both strength training and diet in this preliminary study will be documented to assist the design of a future controlled clinical trial.
Intervention code [1] 318657 0
Rehabilitation
Comparator / control treatment
No control group for this preliminary study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325206 0
Change in lean body mass measured by dual-energy X-ray absorptiometry.
Timepoint [1] 325206 0
Baseline and at the end of eight weeks' training.
Primary outcome [2] 325207 0
Strength testing will involve recording the maximal weight the participant lifts
within 6 to 8 repetitions using the X-Force resistance machines. This assessment is part of the training regimen. For example, for bilateral elbow flexion, the value will be the composite value derived from the simultaneous bilateral activation of biceps brachii, brachioradialis, and brachialis muscles; and for bilateral knee extension the value will be the composite value derived from the simultaneous bilateral activation of the rectus femoris, vastus lateralis, vastus medialis, and vastus intermedius muscles. Changes in an individual muscle's strength e.g., a single elbow flexor (biceps), or a single knee extensor (vastus medialis), will not be assessed.

Timepoint [2] 325207 0
At baseline and eight weeks after commencing strength training and a low-calorie diet.
Secondary outcome [1] 387176 0
Change in waist and hip circumferences using a tape measure.
Timepoint [1] 387176 0
Baseline and eight weeks after commencing strength training and a low-calorie diet.
Secondary outcome [2] 387177 0
Change in body mass measured on a digital scale.
Timepoint [2] 387177 0
Baseline and eight weeks after commencing strength training and a low-calorie diet.
Secondary outcome [3] 387178 0
Change in resting blood pressure at the brachial artery using a calibrated sphygmomanometer.
Timepoint [3] 387178 0
Baseline and eight weeks after commencing strength training and a low-calorie diet.
Secondary outcome [4] 387179 0
Change in glycated haemoglobin level (HbA1c) from a finger prick sample.
Timepoint [4] 387179 0
Baseline and eight weeks after commencing strength training and a low-calorie diet.

Eligibility
Key inclusion criteria
Inclusion: Men and women aged 18-69 years old who are members of BodyTech Gym.
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who have a known health condition or injury that will prevent them from exercising to momentary muscular failure on all training equipment, or who have been advised not to engage in resistance exercise or any exercise training by their primary health care physician. Excluded conditions include people with uncontrolled hypertension, chronic heart failure, musculoskeletal disorders, or cancer.
Participants who are currently on a reduced-calorie diet will also be excluded, for example, Weight Watchers or Jenny Craig programmes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will be determining the magnitude of change in the outcome variables to determine an adequate sample size required to effectively power a subsequent controlled trial. Linear models will be used to determine the magnitude of changes and effect sizes.
For this preliminary study, the sample size was estimated from changes in the outcomes reported across a range of published research, e.g. lean body mass, HbA1c.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
30/11/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 23009 0
New Zealand
State/province [1] 23009 0
Auckland

Funding & Sponsors
Funding source category [1] 306800 0
Commercial sector/Industry
Name [1] 306800 0
Neil Group Limited, a property development company in NZ.
Country [1] 306800 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Exercise Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307354 0
Commercial sector/Industry
Name [1] 307354 0
Neil Group Ltd
Address [1] 307354 0
Neil Group Ltd
8 Nugent St,
Level 3, Building B,
Grafton,
Auckland 1023
New Zealand
Country [1] 307354 0
New Zealand
Other collaborator category [1] 281485 0
Commercial sector/Industry
Name [1] 281485 0
BodyTech Gym
Address [1] 281485 0
BodyTech Gym
8 Nugent Street, Grafton, Auckland 1023
Country [1] 281485 0
New Zealand
Other collaborator category [2] 281487 0
Commercial sector/Industry
Name [2] 281487 0
ExerScience Clinic
Address [2] 281487 0
ExerScience Clinic
Building A/8 Nugent Street, Grafton, Auckland 1023
Country [2] 281487 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306958 0
The Northern A Health and Disability Ethics Committee, New Zealand
Ethics committee address [1] 306958 0
Ethics committee country [1] 306958 0
New Zealand
Date submitted for ethics approval [1] 306958 0
17/10/2019
Approval date [1] 306958 0
20/08/2020
Ethics approval number [1] 306958 0
20/NTA/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105586 0
A/Prof James Stinear
Address 105586 0
Department of Exercise Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 105586 0
New Zealand
Phone 105586 0
+6421992566
Fax 105586 0
Email 105586 0
[email protected]
Contact person for public queries
Name 105587 0
James Stinear
Address 105587 0
Department of Exercise Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 105587 0
New Zealand
Phone 105587 0
+6421992566
Fax 105587 0
Email 105587 0
[email protected]
Contact person for scientific queries
Name 105588 0
James Stinear
Address 105588 0
Department of Exercise Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 105588 0
New Zealand
Phone 105588 0
+6421992566
Fax 105588 0
Email 105588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.