ICOPE INTENSE-K Pilot Study

Summary

ICOPE could constitute the reference model of care for healthy aging. More specifically, our hypothesis is that the intervention implemented in ICOPE may directly or indirectly prevent immuno-senescence, the loss of mobility and the cognitive decline. In future Geroscience clinical trials, ICOPE-Intense could become a benchmark to reduce the rate of aging with a strong non-pharmacological intervention and state a reference intervention to compare with new gerotherapeutic drugs.

Conditions

• Ageing

Interventions

OTHER

ICOPE intense intervention

The ICOPE-intense intervention (45 hours centre-based (in-group and in-person) multidomain intervention, everyday home-based lifestyle improvement, and weekly individual phone/video call for support)

DIETARY_SUPPLEMENT

Ketone Ester (KE) supplementation

12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.

DIETARY_SUPPLEMENT

Placebo

2.5 g of nonketogenic canola oil

DIETARY_SUPPLEMENT

Vitamin D3

2 sprays (i.e. 2000 iu) per day in the morning for 60 days

DIETARY_SUPPLEMENT

OMega 3

1000 mg: 1 table per day in the morning during 60 days

DIETARY_SUPPLEMENT

vitamin B9

5 mg cp: 1 tablet morning and 1 tablet evening for 60 days

DIETARY_SUPPLEMENT

Vitamin B12

250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days

DIETARY_SUPPLEMENT

Leucin-rich whey

In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)

OTHER

ICOPE Step 1

usual ICOPE Step 1

Sponsors & Collaborators

• University Hospital, Toulouse

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-09

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• France

Study Locations