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van CCT (UK)

van CCT (UK)

Optimizing Your Healthh program

- candidate number26735
- NTR NumberNTR6214
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-feb-2017
- Secondary IDsP4981012 FrieslandCampina
- Public TitleOptimizing Your Healthh program
- Scientific TitleOptimizing Your Healthh program (ghNvc) - a multi-domain lifestyle intervention to study the effects of specialized milk and exercise on physical performance among apparently healthy community-dwelling Chinese middle aged and older adults
- ACRONYMNutri-Triofit
- hypothesisThis trial will test the hypothesis whether physical performance and overall well-being of the intervention group supplemented with specialized milk and exercise program will improve compared with a control group without the intervention.
- Healt Condition(s) or Problem(s) studiedPhysical functioning, Vitamin D
- Inclusion criteria-Apparently healthy people aged 50 years or older based on FRAIL score and CMMSE
-Chinese origin
-Normally reside in Hong Kong
-Speak and understand Chinese (i.e. Cantonese or Mandarin)
-Willing to follow the study procedures
-Not obese as defined using BMI <27.5 kg/m2
-Normal blood glucose and lipid profile as measured using fasting blood sample
-Normal renal function as measuring using blood eGFR level
- Exclusion criteria-Live in a residential aged care facility;
-Recent (i.e. past 3 months) or concurrent participation in any clinical trial or exercise and/or dietary intervention program;
-Self-reported allergy or intolerance to the ingredients of the nutrition supplement;
-Poorly controlled or unstable chronic obstructive pulmonary disease;
-Poorly controlled or unstable cardiovascular disease or hypertension;
-Recent unhealed bone fracture (within the past 24 months);
-In treatment for diagnosed cancer
-With medical advice or conditions prohibiting exercise or medical conditions that precluded safe participation in an exercise program;
-With any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study.
-Regular supplementation of calcium, vitamin D or multivitamin containing calcium and/or vitamin D, and Tradition Chinese Medicine (TCM)
-With existing illnesses 2 weeks prior to study
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-mrt-2017
- planned closingdate7-mrt-2018
- Target number of participants180
- InterventionsThe intervention group will receive milk supplements twice a day. They will also participate in an exercise program designed for them.
- Primary outcomeThe change in gait speed over 24 weeks.
- Secondary outcomeBone markers, heart markers, physical performance, assessment of muscle, heart and cognition functions
- Timepointsbaseline & 24 weeks
Anthropometry & BP
Biochemical biomarkers
Gait speed
Functional biomarkers
Functional outcomes
Nutrient biomarkers
Nutrient intake: 3-day food record 12 weeks
Anthropometry & BP
Biochemical biomarkers
Functional biomarkers ( e.g. bone marker
- Trial web site
- statusplanned
- Sponsor/Initiator FrieslandCampina, Chinese University of Hong Kong
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryIt is estimated that worldwide by 2050 there will be over 2 billion people aged 60 and over, more than twice the number measured in 2000 (605 million), with almost 400 million of them aged 80+. All across Asia, the number of people aged 60 and above is expected to grow dramatically over the next 30 years. For the region as a whole, the population in this age group will increase from 508 million in 2015 to 844.5 million in 2030.1 For that reason the pressure to improve health and quality of life with aging is increasing. Especially since scientific evidence is compelling that onset or progress of ageing related pathologies such as osteoporosis, cardiovascular problems and loss of memory function can be delayed by changes in life-style, such as nutrition and physical activity. In other words, besides lifestyle, nutritional imbalances have to be detected and repaired where possible.
This trial will test the hypothesis whether physical performance and overall well-being of the intervention group supplemented with specialized milk and exercise program will improve compared with a control group without the intervention. It will be an 18-month covering randomized clinical trial (RCT). Eligible subjects will be randomly assigned with stratification for gender and age to one of the two groups: an intervention group with 24-week multi-domain intervention, or a control group without intervention.
- Main changes (audit trail)
- RECORD21-feb-2017 - 8-mrt-2017

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