Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly

NCT07356440 | Enrolling By Invitation

• 1 other identifier: CEUR-2024-Sper-39
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Microbiome Analysis; Biomarkers / Blood; Sarcopenia in Elderly; Sarcopenia; Nutritional Intervention; Muscle Mass and Strength; Quality of Life Outcomes

Keywords

sarcopenia; elderly; pea proteins; vitamin D; snack

Outcome Measures

Primary Outcomes (1)

• Change in Appendicular Skeletal Muscle Index (ASMI)

  ASMI calculated as appendicular skeletal muscle mass in kilograms divided by height in meters squared (kg/m²). ASM and height will be measured separately and combined using this formula: "kg/m²". ASMI values \<7 kg/m2 for men, and \<5.5 kg/m2 for women indicate the condition of sarcopenia as indicated by the European Working Group on Sarcopenia in Older People.

  Screening, baseline, week 6 and week 12 (end of the treatment)

Secondary Outcomes (19)

• 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)

Other Outcomes (3)

• Appendicular skeletal muscle mass (ASM)

  Screening, baseline, week 6, week 12 (end of the treatment)

• Height

  screening, baseline

• Body weight

  screening, baseline, week 6, week 12 (end of the treatment)

Study Arms (2)

Protein-enriched biscuit + Vitamin D3

EXPERIMENTAL

Participants will consume daily one portion (50 g) of experimental biscuits made with wheat flour and pea protein hydrolysate, and take 2 drops of vitamin D3 supplement in extra virgin olive oil.

Dietary Supplement: Vitamin D3 supplement; Other: Protein-enriched biscuits

Control Biscuit + Placebo Oil

PLACEBO COMPARATOR

Participants will consume daily one portion (50 g) of control biscuits (same recipe without pea protein hydrolysate), and take 2 drops of placebo oil (extra virgin olive oil without vitamin D3).

Other: Control biscuit; Other: Placebo oil

Interventions

Vitamin D3 supplement DIETARY_SUPPLEMENT

Two daily drops of vitamin D3 dissolved in extra virgin olive oil. Used in the Experimental Arm.

Protein-enriched biscuit + Vitamin D3

Protein-enriched biscuits OTHER

Daily portion (50 g) of biscuits made with wheat flour and pea protein hydrolysate. Used in the Experimental Arm.

Protein-enriched biscuit + Vitamin D3

Control biscuit OTHER

Daily portion (50 g) of control biscuits made with wheat flour, without pea protein hydrolysate.

Control Biscuit + Placebo Oil

Placebo oil OTHER

Two daily drops of placebo oil (extra virgin olive oil without vitamin D3).

Control Biscuit + Placebo Oil

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Given the multifactorial, heterogeneous nature of sarcopenia, volunteers will be enrolled if they meet at least one of the following three diagnostic criteria :
• Ishii equation values: patients with a score ≥105 for males and ≥120 for females will be included. The Ishii screening test is a widely used method that estimates the probability of sarcopenia using a score derived from an equation based on three variables: age, grip strength, and calf circumference.
• Appendicular skeletal muscle mass index (ASMI): \<7.0 kg/m2 for males and \<5.5 kg/m2 for females.
• Short physical performance battery score ≤8
• Body mass index ≥19 \<30 kg/m2
• Ability to act

You may not qualify if:

• Age \<65 or \>80 years;
• Body mass index \<19 or ≥30 kg/m²;
• Diagnosis of cancer within the previous five years;
• Regular intake of vitamin D supplements;
• Dysphagia and difficulty chewing;
• Allergy or other intolerances to gluten;
• Allergy to eggs;
• Intestinal disorders (Crohn's disease, ulcerative colitis, bacterial overgrowth syndrome, constipation, coeliac disease, irritable bowel syndrome) that could affect the gut microbiota;
• Pacemaker recipients;
• Acute inflammation (CRP \>10 mg/L);
• Anaemia (haemoglobin \<13 g/dL in men; \<12 g/dL in women);
• Renal failure (glomerular filtration rate (GFR) \>45 mL/min/1.73 m²);
• Chronic liver disease (transaminases \< 40 IU in men, \< 35 IU/L in women);
• Inability to act

Sponsors & Collaborators

• University of Udine: lead

Study Sites (3)

Department of Agricultural, Food, Environmental and Animal Sciences

Udine, Udine, 33100, Italy

Location

Laboratory of Immunology, Department of Medicine

Udine, Udine, 33100, Italy

Location

Outpatient Clinic of Internal Medicine 2, Central Friuli University Health Authority (ASU FC)

Udine, Udine, 33100, Italy

Location

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• From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.

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MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Alessandro Cavarape, M.D.

  Azienda Sanitaria Universitaria del Friuli Centrale (ASU FC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: December 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)