None listed
Conditions
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. 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
Study design
Eligibility
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.)