Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)

Summary

The main objective of the present study is to add knowledge of the potential health effects and mechanism of action by a dietary strategy based on a VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or combination with prebiotic supplementation based on fructooligosaccharides (FOS) and inulin to tackle sarcopenia by improving skeletal muscle mass and function and CVD risk factors in early elderly (60-80 years) home-dwelling sarcopenic subjects.

The specific objectives:

* To determine the compliance food intake biomarkers of VOO in 24h urine samples and prebiotic intake in faecal samples.
* To evaluate the effect of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) on the improvement of muscle mass, muscle performance, gait performance, cardiovascular disease risk factors (inflammation, oxidation and endothelial function), and gut microbiota, in sarcopenic young-elderly subjects.
* To assess the mechanisms of action of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) involved in the development of sarcopenia and cardiovascular disease in vivo and in vitro cellular models.
* To determine if the effects achieved after the intervention (12 weeks of intervention) will be sustained 12 weeks after the FOOP-Sarc intervention cessation (12 weeks of intervention + 12 weeks of follow-up), by assessing the sarcopenia and CVD risk factors in sarcopenic early elderly subjects.
* To co-create nutritional and physical activity recommendations of FOOP-Sarc study based on sarcopenia improvement by a sample of volunteers of the FOOP-Sarc study, and to assess the adherence and the effectivity of the recommendations, in comparison to standard recommendations created by researchers, the satisfaction and engagement experience in a co-creation process, and the usability of recommendations.

Conditions

• Sarcopenia

Interventions

DIETARY_SUPPLEMENT

Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil)

The dosage will be 30 ml/day of refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil) used as a dressing (without heat).

DIETARY_SUPPLEMENT

Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil)

The dosage will be 30 ml/day of virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) used as a dressing (without heat).

DIETARY_SUPPLEMENT

Maltodextrin

The dosage will be 7,5 g/day of maltodextrin.

DIETARY_SUPPLEMENT

Prebiotic (FOS and inulin)

The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin).

OTHER

Nutritional and physical activity recommendations

The nutritional recommendations are based on DASH diet and foods rich in protein (in particular, leucine) and vitamin D, polyunsaturated acids, phosphorus and iron. The physical activity recommendations are 150 min/week of physical activity, with at least two sessions dedicated to the development of motor strength.

Sponsors & Collaborators

• University Rovira i Virgili

  lead OTHER

Principal Investigators

• Rosa Solà, Dr · University Rovira i Virgili, Reus, Tarragona, Spain

• Rosa Maria Valls, Dr · University Rovira i Virgili, Reus, Tarragona, Spain

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2023-05-31

Completion

2024-05-31

Countries

• Spain

Study Locations