Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03712306
Other study ID # 678732
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 11, 2018
Est. completion date August 14, 2020

Study information

Verified date September 2020
Source VU University of Amsterdam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this RCT with the duration of 6 months among 264 community-dwelling older adults (65+ years) with habitual low protein intake, the investigators will examine the long term (cost) effectiveness of increasing daily protein intake to at least 1.2 gram/kg of adjusted body weight on physical functioning in older adults with low protein intake.


Description:

Read more »
Read more »

Study Design


Intervention

Other:
Dietary advice
Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d
Dietary advice and advice on timing
Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d plus advice on consuming protein in close proximity of usual physical activity

Locations

Country Name City State
Finland University of Helsinki Helsinki
Netherlands Vrije Universiteit Amsterdam Amsterdam Noord Holland

Sponsors (3)

Lead Sponsor Collaborator
VU University of Amsterdam University of Helsinki, VU University Medical Center

Countries where clinical trial is conducted

Finland,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Effectiveness of persuasive technology sub-study on protein intake Examine the effect of persuasive technology on adherence to increasing protein intake. A subsample of the Dutch participants will receive a food storage box that can measure which protein rich food products are taken out and a small-size screen (tablet) that provides reminders and nudges. The investigators will test if there are differences in adherence to the interventions between participants who took part in this sub-study and participants who did not. 6 months
Other Microbiota sub-study The effect of increasing protein intake to at least 1.2 g/kg body weight/d on faecal and oral microbiota composition 6 months
Other Effect of protein intake on satiety and reward responses measured by functional magnetic resonance imaging To examine the effects of increasing protein intake on food-stimuli related central nervous system satiety and reward responses involved in the regulation of food intake, measured by functional magnetic resonance imaging.
BOLD fMRI will be used to measure neuronal activity in CNS satiety and reward circuits (including striatum, amygdala, orbitofrontal cortex, insula) in response to visual food stimuli (pictures of food items) and to the actual consumption of food (chocolate milk).
6 months
Primary 6-month change in walk time on a 400 meter walk test Change in walk time on a 400 meter walk test 6 months
Secondary 6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB) SPPB consists of three tests: repeated chair stands test, 4 meter walk test, and tandem stand test. The total score ranges from 0-12. A higher score indicates better physical functioning. 6 months
Secondary 6-month change in hand grip strength Hand grip strength measured by a hand held dynamometer 6 months
Secondary 6-month change in leg strength Upper leg strength measured by a measurement chair 6 months
Secondary 6-month change in body composition Body composition (fat-free mass, skeletal muscle mass and fat mass) will be assessed from bioelectrical impedance using body resistance, reactance, impedance and phase angle. In the Dutch sample only, fat-free mass and fat mass will be directly measured by using densitometry (BODPOD). 6 months
Secondary 3, and 6-moths self-reported mobility limitations (questionnaire) Mobility limitations will be assessed by means of a questionnaire; "Because of your health, how much difficulty do you have walking 400 meter?" and "Because of your health, how much difficulty do you have climbing one flight of stairs?" Participants responded using a five level Likert scale: 'No difficulty', 'a little difficulty', 'some difficulty', 'a lot of difficulty', and 'unable to do the activity'. 3 and 6 months
Secondary 3, and 6-moths self perceived quality of life Quality of life measured using the EuroQol-5D instrument. The EuroQol 5D consists of five questions on a Likert scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Answer categories range from (1) 'no problems' to (5) 'unable to'. An additional thermometer for experienced health is scored on a Visual Analogue scale (VAS), ranging from 0-100. The exact point where the line crosses the VAS is the VAS score. The scores are converted to an index value, which facilitates the calculation of quality-adjusted life years (QALYs) that is used to calculate the cost-effectiveness of the study. 3 and 6 months
Secondary Incident frailty assessed by the Fried Frailty Index Frailty will be determined using the 5 criteria of the Fried Frailty Index:
Self-reported unintentional weight loss: >4 kg in past 6 months.
Self-reported exhaustion. Based on two self-reported questions from the Center for Epidemiologic Studies Depression scale on exhaustion in the past week at baseline and follow-up: "I felt that everything I did was an effort" and "I could not get going". Scores ranges from 1 'not at all' to 4 'most of the time'. A score of 3 or 4 on either question indicates exhaustion.
Weakness: grip strength in the lowest 20% of the study population, adjusted for gender and BMI.
Slow walking speed: walk time on the 400 meter walk test in the slowest 20% of the study population, adjusted for gender and height.
Low physical activity: Kilocalories expended/wk based on accelerometer data in the lowest quintile of physical activity for each gender.
Outcome:
No components:robust
1 or 2 components:intermediate/prefrail 3 or more components:frail
6 months
Secondary Incidence of sarcopenia risk Incidence of sarcopenia risk will be assessed with the SARC-F questionnaire; how much effort do you experience when 1) lifting and carrying a bag of 4.5 kilo, 2) walking across a room, 3) transferring from a chair or bed, 4) climbing a flight of 10 stairs, and 5) how many times have you fallen in the past year. Answering option include no effort (0 points), a bit of effort (1 point) and a lot of effort (2 points), where a score equal to or greater than 4 is predictive of sarcopenia and poor outcomes. 3 and 6 months
Secondary Incident malnutrition BMI<22 kg/m2 and unintentional weight loss >5% over 6 months 6 months
Secondary 3, and 6-moths health care costs assessed by questionnaire To measure health care costs the investigators will use a modified version of the Resource Utilization in Dementia Questionnaire WIMO. This questionnaire contains questions on hospital admissions, prescribed medicine use, care from health professionals, and use of other health care services in the past three months. These are the domains that the investigators might expect changes in due to the intervention. 3 and 6 months
Secondary 3, and 6-month change in body weight Body weight (kg) will be measured to the nearest 0,1 kg using a calibrated scale. 3 and 6 months
Secondary Body height Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer. baseline
Secondary 3, and 6-month change in body mass index (BMI) Based on measured weight (measured at baseline and after 6 months) and height (measured at baseline) BMI will be calculated as body weight (kg) divided by height (m) squared. 3 and 6 months
Secondary Dietary intake assesed by three 24-hour recalls A 24-hour recall is a structured interview intended to capture detailed information about all foods and beverages consumed by the participant in the past 24 hours. Changes in dietary intake (based on data of the 24-hour recalls) enables to investigate compliance; i.e. higher protein intake indicates higher compliance. 3 and 6 months
Secondary Physical activity Physical activity will be objectively assessed by means of an accelerometer (Axivity, AX3) during 7 subsequent days after each clinic visit. 3 and 6 months
See also
  Status Clinical Trial Phase
Completed NCT03305731 - Activating Behavior for Lasting Engagement After Stroke N/A
Not yet recruiting NCT05975476 - Comparison of Two Park-Based Activities on Emotional Well-Being in Adults With Mobility Impairments N/A
Completed NCT02604082 - Comparison of Three Technical Airway Clearance in Mechanical Ventilated Patients N/A
Completed NCT01417585 - A Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke N/A
Completed NCT01472263 - Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases Phase 3
Recruiting NCT06331858 - The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT05516030 - HIFT for People With Mobility-Related Disabilities N/A
Recruiting NCT04591574 - ABC - A Post Intensive Care Anaemia Management Trial N/A
Completed NCT04562662 - Evaluation of mediVR-KAGURA Guided Therapy N/A
Terminated NCT03696082 - A Precision Rehabilitation Approach to Counteract Age-Related Cognitive Declines N/A
Completed NCT04433962 - Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty N/A
Completed NCT03545932 - Self-perception of Health Status and Physical Condition of Elderly People Practitioners of Hydrogymnastics N/A
Not yet recruiting NCT06264362 - Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia N/A
Completed NCT02592265 - Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden N/A
Completed NCT02926313 - The Effectiveness of Specialist Seating Provision for Nursing Home Residents N/A
Completed NCT02110290 - Effects of an Adapted Ski/Snowboarding Program on Quality of Life in Children With Physical Disabilities
Active, not recruiting NCT01646632 - Exercise Intervention in Institutionalized Elderly People Phase 2
Completed NCT00164476 - Promoting Clinical Preventive Services Among Adults With Disabilities Phase 1
Completed NCT02082171 - Multidomain Intervention to Prevent Disability in Elders N/A