{"type":"trials","record":{"id":21568,"source_id":"clinicaltrials-gov","external_id":"NCT07356440","title":"Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly","brief_summary":"The ageing population makes it necessary to find effective strategies for the prevention of sarcopenia (the progressive loss of muscle mass and strength and a decline in physical performance) that can be counteracted with foods containing protein and adequate intake of vitamin D. This study will evaluate the effectiveness of consuming a food based on plant proteins and vitamin D supplementation. Intervention studies in humans conducted to date have mostly focused on the effect of animal proteins (mainly from whey) on disease progression. A study on the effect of pea proteins has not yet been conducted and will provide information on the effectiveness of these proteins in modulating markers linked to the disease. The effect on the gut microbiota will also be considered, as the existence of a gut-muscle axis has been suggested, in which microbial genera producing short-chain fatty acids have been linked to a positive effect on muscle mass through anabolic stimulation. Thus, the analysis of the modulation of the intestinal microbiota, through the dietary intervention proposed in this study, may represent a further step in research related to the prevention of this disease. Sarcopenic volunteers aged between 65 and 80 will be recruited to consume either a shortbread biscuit made with wheat flour enriched with hydrolysed pea protein and a vitamin D supplement in extra virgin olive oil, or a control biscuit and a placebo (extra virgin olive oil) for 12 weeks. The study will be randomised, parallel, single-blind. The effect of consuming the experimental biscuit and vitamin D supplementation compared to that of a traditional control biscuit and a placebo oil solution will be evaluated on certain markers related to sarcopenia. In particular, the following will be considered: muscle strength, measuring grip strength and leg strength (chair stand test); muscle mass through the measurement of appendicular muscle mass, and the calculation of the appendicular muscle mass index; physical performance using the Short Physical Performance Battery; the inflammatory response and other blood biomarkers related to sarcopenia. In addition, the following will be assessed: dietary habits through a food diary and quality of life through the SarQoL questionnaire. Finally, the effect of nutritional intervention on the modulation of the gut microbiota will be evaluated through 16S rRNA sequencing and bioinformatic analysis of the data.","overall_status":"Active Not Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Udine","enrollment":74,"countries":["Italy"],"start_date":"2025-12-01","completion_date":"2026-12-01","last_update_date":"2026-07-27","source_url":"https://clinicaltrials.gov/study/NCT07356440","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:07.557436+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"SARC-PEA","age_range":"65 Years to 80 Years","comparator":"Control Biscuit + Placebo Oil","organization":"University of Udine","interventions":["Vitamin D3 supplement","Protein-enriched biscuits","Control biscuit","Placebo oil"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in Appendicular Skeletal Muscle Index (ASMI) — Screening, baseline, week 6 and week 12 (end of the treatment)","Muscle strenght — Screening, baseline, week 6 and week 12 (end of the treatment)","Physical performance (SPPB score) — Screening, baseline, week 6 and week 12 (end of the treatment)","C-Reactive protein (CRP) — Baseline, week 6 and week 12 (end of the treatment)","Gut micorbiome modulation and metabolites — Baseline at at week 12 (end of the treatment)","Nutritional intake — Baseline, week 6 and week 12 (end of the treatment)","Nutritional habits — Enrollment","Quality of life of sarcopenic patients — Baseline, week 6 and week 12 (end of the treatment)","Mini Nutritional Assessment (MNA®) — At the screening","Mini Mental State Examination (MMSE) — At the screening","Body mass index (BMI) — screening, baseline, week 6, week 12 (end of the treatment)","Interleukin-6 (IL-6) — baseline, week 6, week 12 (end of the treatment)","Tumor Necrosis Factor-alpha (TNF-α) — baseline, week 6, week 12 (end of the treatment)","Leptin — baseline, week 6, week 12 (end of the treatment)","IGF-1 — Baseline, week 6, week 12 (end of the treatment)","Albumin — baseline, week 6, week 12 (end of the treatment)","Oxidized LDL (oxLDL) — baseline, week 6 and week 12 (end of the treatment)","25OH-D (Total 25-OH Vitamin D) — baseline, week 6, week 12 (end of the treatment)","Human Agrin (C-terminal fragment) — baseline, week 6, week 12 (end of the treatment)","Triglyceride (TG) — baseline, week 6, week 12 (end of the treatment)"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Sarcopenia in Elderly","Sarcopenia","Nutritional Intervention","Microbiome Analysis","Muscle Mass and Strength","Biomarkers / Blood","Quality of Life Outcomes","Vitamin D3 supplement","Protein-enriched biscuits","Control biscuit","Placebo oil"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct07356440","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-12-01 to 2026-12-01","comparator":"Control Biscuit + Placebo Oil","confidence":"structured-source","population":"ALL · 65 Years to 80 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:25.766Z","intervention":["Vitamin D3 supplement","Protein-enriched biscuits","Control biscuit","Placebo oil"],"participants":74,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change in Appendicular Skeletal Muscle Index (ASMI) — Screening, baseline, week 6 and week 12 (end of the treatment)","Muscle strenght — Screening, baseline, week 6 and week 12 (end of the treatment)","Physical performance (SPPB score) — Screening, baseline, week 6 and week 12 (end of the treatment)","C-Reactive protein (CRP) — Baseline, week 6 and week 12 (end of the treatment)","Gut micorbiome modulation and metabolites — Baseline at at week 12 (end of the treatment)","Nutritional intake — Baseline, week 6 and week 12 (end of the treatment)","Nutritional habits — Enrollment","Quality of life of sarcopenic patients — Baseline, week 6 and week 12 (end of the treatment)","Mini Nutritional Assessment (MNA®) — At the screening","Mini Mental State Examination (MMSE) — At the screening","Body mass index (BMI) — screening, baseline, week 6, week 12 (end of the treatment)","Interleukin-6 (IL-6) — baseline, week 6, week 12 (end of the treatment)","Tumor Necrosis Factor-alpha (TNF-α) — baseline, week 6, week 12 (end of the treatment)","Leptin — baseline, week 6, week 12 (end of the treatment)","IGF-1 — Baseline, week 6, week 12 (end of the treatment)","Albumin — baseline, week 6, week 12 (end of the treatment)","Oxidized LDL (oxLDL) — baseline, week 6 and week 12 (end of the treatment)","25OH-D (Total 25-OH Vitamin D) — baseline, week 6, week 12 (end of the treatment)","Human Agrin (C-terminal fragment) — baseline, week 6, week 12 (end of the treatment)","Triglyceride (TG) — baseline, week 6, week 12 (end of the treatment)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sarcopenia","is_published":true,"match_reasons":["Title contains controlled term: sarcopenia.","Abstract contains controlled term: sarcopenia.","Source terminology contains: sarcopenia.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sarcopenia","slug":"sarcopenia"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21568","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}