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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- 6-month change in walk time on a 400 meter walk test
研究概览
简要总结
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.
详细描述
In this RCT with the duration of 6 months the investigators will examine the long term (cost) effectiveness of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on physical functioning in older adults with habitual low protein intake. Additionally, the investigators will examine the combined effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity on physical functioning in older adults with habitual low protein intake.
Three sub-studies will be conducted, of which the main objectives are to:
- Examine the effect of persuasive technology on adherence to consumption of protein rich food products in order to increase protein intake to at least 1.2 g/kg adjusted body weight/d, and to the combination of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity.
- Examine the effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on faecal and oral microbiota composition in older adults with a habitual low protein intake.
- Examine the effects of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on food-stimuli related central nervous system satiety and reward responses involved in the regulation of food intake, measured by functional magnetic resonance imaging in older adults with a habitual low protein intake.
Study design: Randomized controlled trial with the duration of 6 months in two study sites: Amsterdam, the Netherlands and Helsinki, Finland. Stratification by gender and habitual protein intake (low protein (>=0.9 g/kg BW/day - <1.0 g/kg BW/day), very low protein (<0.9 g/kg BW/day)).
Study population: A total of 264 community-dwelling older adults aged ≥ 65 years with an habitual low protein intake (n=132 at each study site).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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);
- •Purposefully lost/gained > 3 kg in the past three months
- •Heart problems in the past three months (heart attack, angioplasty, heart surgery, stroke or other serious heart disease)
- •Not able to complete the 400 meter walk test within 15 minutes (self-reported, and assessed at study baseline).
- •Alcohol abuse past 6 months (AUDIT-C ≥ 2);
- •Low cognitive status, defined as the mini-mental state examination (MMSE) score ≤ 20
- •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);
研究组 & 干预措施
Control group
No intervention. Participants will only receive a brochure on general healthy eating habits.
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.
干预措施: Dietary advice (Other)
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.
干预措施: Dietary advice and advice on timing (Other)
结局指标
主要结局
6-month change in walk time on a 400 meter walk test
时间窗: 6 months
Change in walk time on a 400 meter walk test
次要结局
- 6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB)(6 months)
- 6-month change in leg strength(6 months)
- 3, and 6-moths self perceived quality of life(3 and 6 months)
- 3, and 6-month change in body mass index (BMI)(3 and 6 months)
- 6-month change in hand grip strength(6 months)
- 6-month change in body composition(6 months)
- 3, and 6-moths self-reported mobility limitations (questionnaire)(3 and 6 months)
- Incidence of sarcopenia risk(3 and 6 months)
- Incident malnutrition(6 months)
- 3, and 6-moths health care costs assessed by questionnaire(3 and 6 months)
- 3, and 6-month change in body weight(3 and 6 months)
- Body height(baseline)
- Incident frailty assessed by the Fried Frailty Index(6 months)
- Dietary intake assesed by three 24-hour recalls(3 and 6 months)
- Physical activity(3 and 6 months)
研究者
Ilse Reinders
Principal investigator
VU University of Amsterdam