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van CCT (UK)

van CCT (UK)

Growing Old Together.

- candidate number12941
- NTR NumberNTR3499
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jun-2012
- Secondary IDsP11.187 CME LUMC
- Public TitleGrowing Old Together.
- Scientific TitleGrowing Old Together: The effect of a combined caloric restriction and exercise intervention on phenotypic profiles of offspring of families with exceptional longevity and their partners.
- hypothesisPrimary Objective:
To examine whether an intervention of dietary restriction and exercise can bring the phenotypic profiles (with respect to biomarkers of longevity) of normative ageing individuals towards their healthy aging partners (offspring of families with exceptional longevity).

Secondary Objective(s):
1. To examine if such an intervention could still improve the phenotypic profile of the offspring;
2. To examine which (clinical, biochemical, molecular) baseline mediators determine response to treatment.
- Healt Condition(s) or Problem(s) studiedGlucose metabolism , Blood pressure, Cognitive functioning, Physical functioning, Depression, Quality of life, Sleep habits, Lipid metabolism
- Inclusion criteria1. Middle-aged (≤75 years) couples consisting of offspring from long-lived siblings and his/her current partner or in incidental case as single participant;
2. BMI ≥23 and ≤35 kg/m2.
- Exclusion criteria1. Type I or type II diabetes (on diabetic medication);
2. Individuals who have lost or gained ≥3 kg over the past 6 months;
3. Individuals engaged in heavy/intensive physical activity (top sport or physically heavy work);
4. Any disease or condition that seriously affects body weight and/or body composition including active types of cancer, heart failure (NYHA III/VI), COPD (GOLD III/VI);
5. Recent (3 months prior to intervention) immobilisation for longer than 1 week;
6. Psychiatric or behavioural problems (eg, history or clinical manifestation of any eating disorders, vegan dietary lifestyle, major depression);
7. Medication: thyroid medication, immunosuppressive drugs (e.g. prednisone, methotrexat, biologicals (TNF-alpha antagonists etc);
8. Concurrent participation in any other intervention study or weight management program;
9. Exclusion for biopsy: use of anticoagulantia (e.g. coumarines, carbaspirin calcium);
10. Exclusion MR imaging (7 tesla):
A. Claustrophobia;
B. Pacemakers and defibrillators;
C. Nerve stimulators;
D. Intracranial clips;
E. Intraorbital or intraocular metallic fragments;
F. Cochlear implants;
G. Ferromagnetic implants (e.g. thoracic implant for scoliosis);
H. Inability to lie supine during for 45 minutes;
I. not having a general practitioner
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-mrt-2012
- planned closingdate31-mrt-2013
- Target number of participants140
- Interventions3 months (13 weeks) intervention with 25% lowered energy expenditure, of which half (12.5% of energy) through caloric restriction and the other half through an increase in physical activity.
Partners of participants will serve as a control group.
- Primary outcomeChange in fasting insulin level.
- Secondary outcomeBlood parameters (metabolic/metabolomics), parameters measured in biopsies of muscle and fat (transcriptomics/proteomics/epigenetics), anthropometrics, body composition, blood pressure, 24-hour glucose monitoring, energy metabolism (resting metabolic rate), MR imaging (leg, brain, cartilage of the knee) and psychological factors (cognitive performance, mood, quality of life, sleep, hunger).
- TimepointsWeek 0 and week 13. Anthropometrics and hunger and appetite ratings monthly during the intervention.
- Trial web
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIESIr. Ondine Rest, van de
- Sponsor/Initiator Leiden University Medical Center (LUMC), Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Genomics Initiative (NGI)
- PublicationsN/A
- Brief summaryCaloric restriction (CR) is the most effective intervention known to improve age-related health and to slow the aging process, resulting in an increase in both average and maximum lifespan. This has already been shown in a variety of species as diverse as yeast, worms, fish, flies and rodents. From the perspective of human aging these observations are interesting, but the evidence on the effectiveness of caloric restriction on biomarkers of healthy aging in humans is limited. In the Leiden Longevity Study (LLS) we have two groups of individuals to compare in this sense: a healthy ageing group (members of long-lived families) that display a beneficial profile of many metabolic markers and a normative ageing group (the partners of these members) with an average metabolic profile. The longevity families were included by selecting for living nonagenarian sibships (sibpairs or larger sibships) and recruiting these individuals, their offspring and the partners of that offspring. Thus, the LLS harbours a contrast between longevity family members showing many beneficial phenotypes resembling those induced by CR as compared to their partners as controls, although fat intake and BMI do no differ between these groups. Also contrasts in several metabolic outcomes in favour of offspring of long-lived siblings as compared to their partners (controls) have been shown, making this a unique/distinctive study population to examine the effects of CR, in combination with physical exercise, on several biomarkers of healthy aging. It is hypothesized that after the combined CR/exercise intervention the partners closer resemble metabolic outcome variables of the offspring. We intend to include 70 couples (aged <=75 years) from the LLS without diabetes and with a BMI >=23 and <=35 kg/m2, each consisting of an offspring from long-lived siblings (cases enriched for familial longevity) and his/her current partner. They all participate in a 3 months intervention with 25% lowered energy expenditure by 12.5% caloric restriction and 12.5% more exercise, which will be achieved by setting up individual guidelines according the Dutch guidelines for a healthy diet and based on each subject's habitual dietary habits and physical activity pattern. The primary outcome measure is the change in fasting insulin level. Secondary outcome measures are blood parameters (metabolic/metabolomics), parameters measured in biopsies of muscle and fat (transcriptomics/proteomics/epigenetics), anthropometrics, body composition, blood pressure, 24-hour glucose monitoring, energy metabolism (resting metabolic rate), MR imaging (leg, brain, cartilage of the knee) and psychological factors (cognitive performance, mood, quality of life, sleep, hunger).
- Main changes (audit trail)
- RECORD27-jun-2012 - 30-apr-2015

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