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The (Cost)Effectiveness of Increasing Protein Intake on Physical Funtioning in Older Adults

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ClinicalTrials.gov Identifier: NCT03712306
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Helsinki University
VU University Medical Center
Information provided by (Responsible Party):
Ilse Reinders, VU University of Amsterdam

Brief 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.

Condition or disease Intervention/treatment Phase
Protein-Energy Malnutrition Physical Disability Other: Dietary advice Other: Dietary advice and advice on timing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomized intro one of the three study groups.

Stratification by gender and habitual protein intake (low protein (>=0.9 g/kg aBW/day - <1.0 g/kg aBW/day), very low protein (<0.9 g/kg aBW/day)), since we expect a different intervention effect for participants with a very low baseline habitual protein intake (< 0.9 g/kg aBW/d) compared to participants with a low baseline habitual protein intake (≥ 0.9 g/kg aBW/d), and because of potential differences in how women and men respond to the intervention.

In case couples participate, we will make sure they will be allocated to the same intervention group. This will ensure no interference between intervention groups. We will randomly select whether the randomization for the intervention group is based on the men or the women.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The (Cost) Effectiveness of Increasing Daily Protein Intake to 1.2 Gram Per Kilo Body Weight on Physical Functioning in Community-dwelling Older Adults With a Habitual Daily Protein Intake < 1.0 Gram Per Kilo Body Weight
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
No intervention. Participants will only receive a brochure on general healthy eating habits.
Experimental: Dietary advice
Personalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products.
Other: Dietary advice
Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d

Experimental: Dietary advice and advice on timing
Personalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products, as well as advice regarding the consumption of protein rich food products in close proximity of usual physical activity.
Other: 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




Primary Outcome Measures :
  1. 6-month change in walk time on a 400 meter walk test [ Time Frame: 6 months ]
    Change in walk time on a 400 meter walk test


Secondary Outcome Measures :
  1. Dietary intake assesed by three 24-hour recalls [ Time Frame: 3 and 6 months ]
    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.

  2. Malnutrition incidence [ Time Frame: 6 months ]
    BMI<22 kg/m2 and unintentional weight loss >5% over 6 months

  3. 6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB) [ Time Frame: 6 months ]
    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.

  4. 3, and 6-moths self-reported mobility limitations (questionnaire) [ Time Frame: 3 and 6 months ]
    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'.

  5. 6-month change in hand grip strength [ Time Frame: 6 months ]
    Hand grip strength measured by a hand held dynamometer

  6. 6-month change in leg strength [ Time Frame: 6 months ]
    Upper leg strength measured by a measurement chair

  7. 3, and 6-month change in body weight [ Time Frame: 3 and 6 months ]
    Body weight (kg) will be measured to the nearest 0,1 kg using a calibrated scale.

  8. Body height [ Time Frame: baseline ]
    Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer.

  9. 3, and 6-month change in body mass index (BMI) [ Time Frame: 3 and 6 months ]
    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.

  10. 6-month change in body composition [ Time Frame: 6 months ]
    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).

  11. Frailty assessed by the Fried Frailty Index [ Time Frame: 6 months ]

    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


  12. 3, and 6-moths self perceived quality of life [ Time Frame: 3 and 6 months ]
    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.

  13. 3, and 6-moths health care costs assessed by questionnaire [ Time Frame: 3 and 6 months ]
    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.


Other Outcome Measures:
  1. Effectiveness of persuasive technology sub-study on protein intake [ Time Frame: 6 months ]
    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.

  2. Microbiota sub-study [ Time Frame: 6 months ]
    The effect of increasing protein intake to at least 1.2 g/kg body weight/d on faecal and oral microbiota composition

  3. Effect of protein intake on satiety and reward responses measured by functional magnetic resonance imaging [ Time Frame: 6 months ]

    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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age ≥ 65 years;
  • Community-dwelling;
  • Lower protein intake defined as both a probability score above a certain cutoff on the protein screener (www.proteinscreener.nl) as well as based on actual protein intake assessed by 24-hour recalls. The protein screener was developed and validated using an extended FFQ among Dutch older adults. The cutoff will be chosen based on results of different studies in which the investigators compare the probability scores of the protein screener with protein intake as measured with food diaries and/or dietary recalls. The investigators will then choose the probability score that is most closely associated with a protein intake < 1.0 g/kg adjusted body weight/day. This probably score reflects older adults with a higher probability on a protein intake < 1.0 g/kg adjusted body weight/d than a general sample of older adults;
  • Able to eat independently;
  • Willing to eat our provided protein-enriched food products and change food habits;
  • Able to speak, write and read the Dutch language;
  • Able to walk 400 meter, with or without the help of a walking cane (self-reported).

Exclusion criteria:

  • Bedridden or wheelchair bound;
  • Individuals who do not go outside;
  • Individuals with bad hearing (who cannot hear without a hearing aid);
  • Diagnosed with diabetes mellitus type I;
  • Diagnosed with diabetes mellitus type 2 and starting with insulin;
  • Diagnosed with severe kidney disease;
  • Diagnosed with Parkinson's disease;
  • Current treatment of cancer (with the exception of basal cell carcinoma);
  • BMI < 18.5 kg/m2 (self-reported, and assessed at study baseline);
  • Overweight, defined as BMI > 32.0 kg/m2 (self-reported, and assessed at study baseline);
  • Vegan;
  • Severe allergies to certain food products (such as peanuts, gluten);
  • Alcohol abuse past 6 months (AUDIT-C ≥ 2);
  • Diagnosed with an eating disorder (self-reported);
  • Current participation to supervised behavioral or lifestyle intervention that intervenes with PROMISS intervention;
  • Planning to move out of the study area in the next 6 months;
  • Actively trying to lose or gain weight;
  • Heart problems (heart attack, angioplasty, heart surgery, stroke or other serious heart disease)
  • Not able to complete the 400 meter walk test (self-reported, and assessed at study baseline).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712306


Contacts
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Contact: Ilse Reinders, PhD +31205986969 ilse.reinders@vu.nl
Contact: Hanneke Wijnhoven, PhD +31205989282 hanneke.wijnhoven@vu.nl

Locations
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Finland
University of Helsinki Recruiting
Helsinki, Finland
Contact: Merja Suominen, Ad. Prof.    +358505841995    merja.suominen@gery.fi   
Contact: Satu Jyväkorpi, PhD         
Netherlands
Vrije Universiteit Amsterdam Recruiting
Amsterdam, Noord Holland, Netherlands, 1081 HV
Contact: Ilse Reinders, PhD       ilse.reinders@vu.nl   
Contact: Hanneke Wijnhoven, PhD       hanneke.wijnhoven@vu.nl   
Sponsors and Collaborators
VU University of Amsterdam
Helsinki University
VU University Medical Center
Investigators
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Study Chair: Marjolein Visser, Prof., PhD VU University of Amsterdam

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Responsible Party: Ilse Reinders, Principal investigator, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT03712306     History of Changes
Other Study ID Numbers: 678732
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malnutrition
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases