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

NCT03712306 | Completed

• 1 other identifier: 678732
• Study Type: interventional
• Target: 276
• Locations: 2 countries
• Sites: 2

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.

Conditions

Protein-Energy Malnutrition; Physical Disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB)

  6 months

• 6-month change in hand grip strength

  6 months

• 6-month change in leg strength

  6 months

• 6-month change in body composition

  6 months

• 3, and 6-moths self-reported mobility limitations (questionnaire)

  3 and 6 months

Other Outcomes (3)

• Effectiveness of persuasive technology sub-study on protein intake

  6 months

• Microbiota sub-study

  6 months

• Effect of protein intake on satiety and reward responses measured by functional magnetic resonance imaging

  6 months

Study Arms (3)

Control group

NO INTERVENTION

No intervention. Participants will only receive a brochure on general healthy eating habits.

Dietary advice

EXPERIMENTAL

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 and advice on timing

EXPERIMENTAL

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

Interventions

Dietary advice OTHER

Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d

Dietary advice

Dietary advice and advice on timing OTHER

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

Dietary advice and advice on timing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Inability or unwillingness to provide informed consent
• Not able to eat independently;
• Not able to speak, write and read the Dutch language;
• Current participation to supervised behavioral or lifestyle intervention that intervenes with PROMISS intervention;
• Not able the visit the research site in the following next 6 months;
• Bedridden or wheelchair bound;
• Individuals who do not go outside;
• Diagnosed with severe kidney disease;
• Diagnosed with Parkinson's disease;
• Diagnosed with diabetes mellitus type I;
• Diagnosed with diabetes mellitus type 2 and starting with insulin;
• Current treatment of cancer (with the exception of basal cell carcinoma);
• Vegan diet;
• Severe allergies to certain food products (such as peanuts, gluten);
• Diagnosed with an eating disorder (self-reported);

Sponsors & Collaborators

• VU University of Amsterdam: lead
• University of Helsinki: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (2)

University of Helsinki

Helsinki, Finland

Location

Vrije Universiteit Amsterdam

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (3)

• Grasso AC, Olthof MR, Reinders I, Wijnhoven HAH, Visser M, Brouwer IA. Effect of personalized dietary advice to increase protein intake on food consumption and the environmental impact of the diet in community-dwelling older adults: results from the PROMISS trial. Eur J Nutr. 2022 Dec;61(8):4015-4026. doi: 10.1007/s00394-022-02896-x. Epub 2022 Jul 5.

  PMID: 35788775 DERIVED

• Reinders I, Visser M, Jyvakorpi SK, Niskanen RT, Bosmans JE, Jornada Ben A, Brouwer IA, Kuijper LD, Olthof MR, Pitkala KH, Vijlbrief R, Suominen MH, Wijnhoven HAH. The cost effectiveness of personalized dietary advice to increase protein intake in older adults with lower habitual protein intake: a randomized controlled trial. Eur J Nutr. 2022 Feb;61(1):505-520. doi: 10.1007/s00394-021-02675-0. Epub 2021 Oct 5.

  PMID: 34609621 DERIVED

• Reinders I, Wijnhoven HAH, Jyvakorpi SK, Suominen MH, Niskanen R, Bosmans JE, Brouwer IA, Fluitman KS, Klein MCA, Kuijper LD, van der Lubbe LM, Olthof MR, Pitkala KH, Vijlbrief R, Visser M. Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial. BMJ Open. 2020 Nov 20;10(11):e040637. doi: 10.1136/bmjopen-2020-040637.

  PMID: 33444206 DERIVED

MeSH Terms

Conditions

Protein-Energy Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Marjolein Visser, Prof., PhD

  VU University of Amsterdam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: October 19, 2018
• Study Start: October 11, 2018
• Primary Completion: July 31, 2020
• Study Completion: August 14, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); FI (1)