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

University Rovira i Virgili

Status: Enrolling

Conditions: Sarcopenia

Treatments: Dietary Supplement: Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil); Dietary Supplement: Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil); Dietary Supplement: Prebiotic (FOS and inulin); Dietary Supplement: Maltodextrin; Other: Nutritional and physical activity recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT05485402

FOOP-Sarc study

PID2019-105164RB-I00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

The prebiotic supplementation about FOS and inulin was related to gut microbiota transformation an increase in handgrip strength and a reduction of exhaustion in older adults over 65 years old.

In the role of a nutritional intervention for the treatment of sarcopenia, an adequate intake of protein, especially leucine, vitamin D and antioxidant nutrients are recommended. In particular, dietary protein is a key anabolic stimulus for muscle protein synthesis. Moreover, food such as, virgin olive oil (VOO) can be involved in sarcopenia, by modulation of pro-inflammatory cytokines and could attenuate sarcopenic symptomology.

On the other hand, physical activity (PA) is an important aspect to avoid loss of muscle mass, for this reason, in sarcopenic subjects it is recommended to spend 150 min/week of moderate to vigorous physical activity.

A total of 135 home-dwelling early elderly volunteers will be included in the intervention (45 in each arm of the intervention). The total duration of the study will be 24 weeks (12-week period of dietary-lifestyle treatment and a 12-week period of follow-up after intervention cessation). Additionally, a total of 36 home-dwelling early elderly volunteers will be included in the co-creation process. Specifically, 12 home-dwelling early elderly volunteers will participate in the co-ideation and co-design steps. Additionally, 24 home-dwelling early elderly volunteers will participate in the co-implementation and comparison of recommendations (12 in each arm of intervention). The sample of volunteers that will co-implement will be randomized and different from the sample of volunteers that will co-ideate and co-design the recommendations. The co-evaluation step will include all 36 volunteers from the different steps of the co-creation process.

During the preliminary co-creation phase, there will be 5 visits over 5 weeks. The study visits will be the following: screening visit (V0): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; visits during the intervention (V1, V2, V3); and final study visit (V4). The volunteers that will co-ideate and co-design the recommendations will carry out only the V0, V1, V2, and V4. Instead, the co-implement volunteers will carry out only the visits V0, V3, and V4.

Additionally, during the FOOP-Sarc study, there will be 7 visits in total (6 visits during the intervention period and 1 follow-up visit). Of these visits, 4 will be face-to-face and 3 by telephone. The study visits will be the following: screening visit (V0, face-to-face): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; basal visit (V1); visits during the intervention (V2, telephone; V3, telephone; V4, telephone); final study visit (V5, face-to-face); and follow-up visit (V6, face-to-face): follow-up visit 12-week after intervention cessation. In visits V0, V1, V5, and V6 volunteers must present themselves in fasting conditions of 8 hours to obtain blood. In visits V1, V5, and V6 volunteers must bring urine and feaces samples.

Enrollment: 135 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women with and age equal to or greater than 60 years and until 80 years.
• Written informed consent provided before the initial visit.
• Sarcopenia assessment: low muscle strength based on grip dynamometry, kg (men <30 kg; women <20 kg) or low skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 (men <8,87 kg/m2; women <6,42 kg/m2) or low physical performance or physical function based on 4m gait speed, m/s (≤0,8 m/s)

Exclusion criteria

• Type 2 or insulin-dependent diabetes diagnosed.
• Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women).
• Intestinal malabsorption diseases.
• Fructose and/or sucrose intolerance.
• Malnutrition (assessed by albumin <3,5 g/dl).
• Renal diseases.
• Chronic alcoholism.
• Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
• Institutionalized elderly.
• Failure to follow the study guidelines.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 3 patient groups, including a placebo group

Control group (Group A)

Placebo Comparator group

Description:

Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations

Treatment:

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

Other: Nutritional and physical activity recommendations

Dietary Supplement: Maltodextrin

Intervention group (Group B)

Experimental group

Description:

Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations

Treatment:

Other: Nutritional and physical activity recommendations

Dietary Supplement: Maltodextrin

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

Intervention group (Group C)

Experimental group

Description:

Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), prebiotic supplementation (FOS and inulin), and nutritional and physical activity recommendations

Treatment:

Other: Nutritional and physical activity recommendations

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

Dietary Supplement: Prebiotic (FOS and inulin)