Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001630808
Ethics application status
Approved
Date submitted
18/12/2020
Date registered
29/11/2021
Date last updated
7/11/2022
Date data sharing statement initially provided
29/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of snack products on physical performance of older women
Scientific title
The effect of protein and milk fat globule membrane containing snack products on physical performance of older women, randomized controlled trial
Secondary ID [1] 303022 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduced physical performance 320089 0
impaired cognition 320090 0
frailty 320092 0
sarcopenia 320093 0
Condition category
Condition code
Diet and Nutrition 318028 318028 0 0
Other diet and nutrition disorders
Musculoskeletal 318029 318029 0 0
Other muscular and skeletal disorders
Mental Health 320089 320089 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the study participants (n = 102) are randomized into two groups; to an intervention group and to a control group. The participants are older women of 70 years or older, who have mobility limitations. After the randomization taking place after baseline measurements, on bases of the intervention participants' protein intake analyzed from their food records, they will receive 1-2 snack products daily for three months and advise by trained nutritionist on how to use them as part of daily diet. The milk-based snack products are protein rich and contain at least 1 g of milk fat globule membrane that has in previous trials improved physical performance in humans and animals, and 15-30 g of protein (depending on the baseline protein intake of the participant). The intervention participants are advised to time the consumption of the snack products in close proximity with daily physical activity. Both groups (intervention, control) are taught to perform short daily exercise routine containing five exercises planned to improve gate speed and advised to perform the routine independently daily. They will also receive written instruction of the routine. The materials will be readily available. We will use materials provided by the Age institute in Finland. The daily exercise routine will last about 15 minutes to perform. The examples of the daily routine can be found following this link: https://www.voimaavanhuuteen.fi/content/uploads/2016/04/k%C3%A4vely_kevyemm%C3%A4ksi.pdf. We will monitor the adherence to the exercise routine and research product with self-report log, and with product return. We will keep in contact with the participants regularly via phone during the intervention.
Due to the pandemic, the nutritionist will keep in contact with the intervention participants only by phone or computer to give advise remotely to the participants on the consumption of the products. They will also receive written advise on the timing on the consumption of the products. The participants are advised to replace a normal snack or dessert in their diet with the snack product provided by the study in order to keep the intervention weight neutral. However, in case of a participant has low BMI (egual or less than 23 kg/m2), is losing weight involuntarily or has a poor appetite, they will be encouraged to consume the snack products in top of their ordinary daily diet.

The interventionist (nutritionist) will go through training prior to the start of the trial. The snack products will be delivered to the homes of the participants by a delivery service with regular intervals.
Intervention code [1] 319312 0
Rehabilitation
Intervention code [2] 319313 0
Prevention
Intervention code [3] 319314 0
Lifestyle
Comparator / control treatment
The control group will receive no snack products. However, the control and intervention groups will be taught to perform the same short daily exercise routine containing five exercises planned to improve gate speed and advised to perform the routine independently daily. They will also receive written instruction of the routine. The control group will additionally receive a brochure of healthy nutrition and take part of all the measurements. The brochure of healthy nutrition is already available resource found following the link: https://syohyvaa.fi/wp-content/uploads/2016/04/Selkokielinen-Sy%C3%B6-hyv%C3%A4%C3%A4-esite.pdf
Control group
Active

Outcomes
Primary outcome [1] 326016 0
Five times chair stand -test: physical performance, muscle strength
Timepoint [1] 326016 0
Baseline, 3 months post-intervention commencement (end measurement)
Secondary outcome [1] 389879 0
Cognition measured with Trial making test A and B, and verbal fluency test (part of CERAD-test battery)
Timepoint [1] 389879 0
Baseline, at 3 months (end trial)
Secondary outcome [2] 389880 0
The questionnaire is designed for this trial
Falls are recorded with a questionnaire:
- at baseline: have you fallen during past year, how many times, did the fall result an injury, can you specify?
- At 3 months; have you fallen during the past 3 months, how many times, did the fall result an injury, can you specify?
Timepoint [2] 389880 0
At baseline, at 3 months (end trial)
Secondary outcome [3] 389881 0
Frailty phenotype by Fried
Timepoint [3] 389881 0
Baseline, at 3 months (end trial)
Secondary outcome [4] 389882 0
Sarcopenia status according to EWGSOP2-criteria
Timepoint [4] 389882 0
At baseline, 3 months (end trial)
Secondary outcome [5] 389883 0
Body composition measured with In Body- devise
Timepoint [5] 389883 0
Baseline, 3 months (end trial)
Secondary outcome [6] 389884 0
3 day food record with food diary
Timepoint [6] 389884 0
Baseline, 3 months
Secondary outcome [7] 389885 0
Quality of life with RAND-36 (SF-36)
Timepoint [7] 389885 0
Baseline, 3 months (end trial)
Secondary outcome [8] 389886 0
Short Physical Performance Battery
Timepoint [8] 389886 0
Baseline, 3 months (end trial)
Secondary outcome [9] 389887 0
Muscle strength: hand grip strength with hand held dynamometer
Timepoint [9] 389887 0
Baseline, 3 months (end trial)
Secondary outcome [10] 389888 0
Sleep quality and quantity
with questionnaire: how would you rate your sleep quality (very good, good, average, poor)
How many hours do you sleep on average during day?
during night?
Timepoint [10] 389888 0
Baseline, 3 months (end trial)
Secondary outcome [11] 399592 0
BMI; weight will be assessed by digital weight scale and height by human length gauge during the baseline visit and weight will be assessed by digital weight scale at end measurement at the clinic.
Timepoint [11] 399592 0
Baseline, 3 month (end trail)
Secondary outcome [12] 399593 0
waist circumference will be measured with measuring tape at baseline and end visits at the clinic.
Timepoint [12] 399593 0
Baseline, 3 months
Secondary outcome [13] 399594 0
SNAQ-appetite-questionnaire
Timepoint [13] 399594 0
Baseline, 3-months

Eligibility
Key inclusion criteria
Home-dwelling female
Mobility limitations; SARC (A Simple Questionnaire to Rapidly Diagnose Sarcopenia) > 1
Able to move independently
Minimum age
70 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor cognition; MMSE less than 24
Wheel chair or bed bound; no being able to move independently
Self-reported severe kidney disease (on protein restricted diet)
High consumption of alcohol (more than 18 portion per week; AUDIT equal or greater than 3)
Diabetics needing to use insulin injections
Parkinson's disease
Active cancer treatment within a year (except basal cell carcinoma)
Allergy to milk or other special diet (vegan, etc.) that prevents consumption of the snack product provided by the trial
Severe obesity (BMI greater than 35 kg/m2)
Involuntary weight loss (more than 3 kg in 3 months).
Staying long times away from the study area during the trial
Taking part of an other lifestyle/intervention trial simultaneously
Consideration of the investigators that the person will not finish the trial (e. g. lack of motivation, unwillingness to be randomized to the control group etc.)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2021
Date of last participant enrolment
Anticipated
15/12/2021
Actual
15/12/2021
Date of last data collection
Anticipated
31/03/2022
Actual
31/03/2022
Sample size
Target
102
Accrual to date
Final
101
Recruitment outside Australia
Country [1] 23292 0
Finland
State/province [1] 23292 0
Uusimaa

Funding & Sponsors
Funding source category [1] 307433 0
Commercial sector/Industry
Name [1] 307433 0
Valio Oy
Country [1] 307433 0
Finland
Primary sponsor type
Charities/Societies/Foundations
Name
Society for Gerontological Nutrition in Finland
Address
Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland
Country
Finland
Secondary sponsor category [1] 308105 0
None
Name [1] 308105 0
N/A
Address [1] 308105 0
N/A
Country [1] 308105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307514 0
Ethics Committee of the Helsinki University Hospital, Department of Medicine.
Ethics committee address [1] 307514 0
Ethics committee country [1] 307514 0
Finland
Date submitted for ethics approval [1] 307514 0
03/11/2020
Approval date [1] 307514 0
24/11/2020
Ethics approval number [1] 307514 0
HUS/3022/2020-3

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

Contacts
Principal investigator
Name 107510 0
Dr Satu Jyväkorpi
Address 107510 0
The Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland
Country 107510 0
Finland
Phone 107510 0
+358504920970
Fax 107510 0
Email 107510 0
[email protected]
Contact person for public queries
Name 107511 0
Merja Suominen
Address 107511 0
The Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland
Country 107511 0
Finland
Phone 107511 0
+358505841995
Fax 107511 0
Email 107511 0
[email protected]
Contact person for scientific queries
Name 107512 0
Satu Jyväkorpi
Address 107512 0
The Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland
Country 107512 0
Finland
Phone 107512 0
+358504920970
Fax 107512 0
Email 107512 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
Our ethical permission prevents that.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10055Study protocol  [email protected] Upon request from email: [email protected]
10056Informed consent form  [email protected] [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Milk Fat Globule Membrane- and Protein-Containing Snack Product on Physical Performance of Older Women-A Randomized Controlled Trial.2023https://dx.doi.org/10.3390/nu15132922
N.B. These documents automatically identified may not have been verified by the study sponsor.