Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05485402
Status:
RECRUITING
Last Update Posted:
2023-05-19
First Post:
2022-07-26
Brief Title:
Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects FOOP-Sarc
Sponsor:
University Rovira i Virgili
Organization:
University Rovira i Virgili
Study Overview
Official Title:
Foods Such as Virgin Olive Oil Rich in Phenolic Compounds and Prebiotic Supplementation Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects FOOP-Sarc
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOOP-Sarc
Brief 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 tyrosolkg 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 tyrosolkg 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 tyrosolkg 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
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 tyrosolkg 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 tyrosolkg 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
Detailed 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 minweek 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 inclusionexclusion 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 inclusionexclusion 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
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 minweek 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 inclusionexclusion 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 inclusionexclusion 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PID2019-105164RB-I00 | OTHER_GRANT | MCINAEI1013039501100011033 | None |