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The effect of snack products on physical performance of older women

The effect of protein and milk fat globule membrane containing snack products on physical performance of older women, randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001630808
Enrollment
101
Registered
2021-11-29
Start date
2021-11-01
Completion date
2021-12-15
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We investigate the effect of protein and MFGM containing snack products on physical performance of older women of 70 years or over who at baseline have mobility limitations in 12 week RCT, Participants in the IG will consume daily 1-2 snack product that contains protein and MFGM containing 15-30 g of protein and at least 1 g MFGM. The main outcome of the study is physical performance measured with 5 times chair stand test. We hypothesize that the combined effect of protein and MFGM may improve physical performance of older women who have mild mobility limitations .

Interventions

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. T

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.

Sponsors

Society for Gerontological Nutrition in Finland
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Home-dwelling female Mobility limitations; SARC (A Simple Questionnaire to Rapidly Diagnose Sarcopenia) > 1 Able to move independently

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.)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026