Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults
Quality of Life
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 50 años - 70 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 348 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The goal of this intervention study (clinical trial) is to investigate the effect of colon-delivered Riboflavin (vitamin B2) on the faecal microbial composition and diversity in older healthy subjects (50 -70 years of age)
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Participants must be willing and able to give written informed consent and to understand, to participate, and to comply with the clinical study requirements.
2. Between 50 and 70 years of age.
3. Has a BMI of between 18.5 - 30 Kg/m2.
4. Participants have had a stable body weight (≤5 % change) over the past 3-months.
5. Is in general good health, as determined by interview and vital signs (blood pressure, heart rate, pulse) by the investigator.
6. Willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements, and, within 4 weeks prior to the baseline visit, until the end of the study.
7. Maintain current level of physical activity.
8. Willing to consume the investigational product daily for the duration of the study.
9. Female participants in menopause for at least the last one year. -
Exclusion Criteria:
1. Are hypersensitive to any of the components of the test product.
2. Has taken antibiotics within the previous 3 months prior to Baseline (Visit2)
3. Is currently using systemic steroids, systemic antibiotics, proton pump inhibitors, H2 blocker, antacid, metformin, or immunosuppressant medication.
4. Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (\>11 units for women; \>17 units for men); Is currently in treatment for alcohol/substance abuse; Has been diagnosed with alcohol/substance abuse disorder).
5. Is a smoker or vaper.
6. Vegetarian or vegan.
7. Has made any major dietary changes in the past 3 months prior to Baseline (Visit 2).
8. Planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
9. Has a currently active eating disorder.
10. Has food allergies or other issues with foods that would preclude the intake of the study products, as determined by the study investigator.
11. Is having a typical fibre intake \>30 g fibre/day.
12. Has an active gastrointestinal disorder or previous gastrointestinal surgery, which in the opinion of the investigator would impact the study outcomes.
13. If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months to screening and agree to maintain the same dosage throughout the study.
14. Has severe or uncontrolled type 2 diabetes, psychiatric disorder, gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach or duodenal ulcers respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes.
15. Has a current or history of any gastrointestinal cancer
16. Are severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy with the last year).
17. Experiences alarm features such as weight loss, rectal bleeding, a recent change in bowel habit (\<3 months).
18. Have a current malignant disease or any concomitant end-stage organ disease.
19. Individuals who, in the opinion of the investigator are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
20. Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
21. Participants who have undergone intensive skin treatments (e.g. laser treatment or skin related surgery) in the last 3 months.
22. If taking any dietary supplements or medications known to affect skin health or other trial measures (resveratrol, ginkgo biloba, ginseng, fruit powder extracts and DHA).
23. Has a skin condition likely to interfere with skin assessments (e.g., eczema, dermatitis, any open skin wounds, reactive and sensitive skin).
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Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Low dose
Daily dose of 1.4 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks
Dietary Supplement: Riboflavin
Mid dose
Daily dose of 10 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks
Dietary Supplement: Riboflavin
high dose
Daily dose of 75 mg Vitamin B2 (Riboflavin) once a day for 12 weeks
Dietary Supplement: Riboflavin
Placebo
One capsule of 570 mg (consisting of microcrystalline cellulose) once a day for 12 weeks
Dietary Supplement: Riboflavin
Riboflavin DIETARY_SUPPLEMENT
Colon delivered vitamin B2 (Riboflavin) for 12 weeks
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Faecal microbial composition
Plazo: from baseline to 12 weeks
Faecal microbial composition at phylum, genus, and species levels, as measured by metagenomic based profiles at baseline and at week 12
Medidas secundarias
Alpha diversity
Plazo: from baseline to 12 weeks
Alpha diversity (Observed, Chao Index, Simpson Index, Shannon Index) at baseline and week 12.
Beta diversity
Plazo: week 0 to week 12
Beta diversity (Jaccard, Bray Curtis, Aitchson) at baseline and week 12
Faecal microbial metabolites fatty acid content at baseline and week 12
Plazo: from baseline to 12 weeks
Faecal microbial metabolites measured as total short-chain fatty acid content at baseline and week 12
Acetate, Propionate and Butyrate
Plazo: baseline and week 12
Acetate, Propionate and Butyrate SCFAs (µmol/g) at baseline and week 12.
Intestinal inflammation
Plazo: from baseline to 12 weeks
Intestinal barrier integrity as assessed by sCD14 at baseline and at week 12
Intestinal barrier integrity
Plazo: from baseline to 12 weeks
Oxidative stress level measured as free thiol content in blood at baseline and at week 12
Oxidative stress in blood
Plazo: from baseline to 12 weeks
Oxidative stress level measured as free thiol content in blood at baseline and at week 12
Inflammatory status in blood
Plazo: from baseline to 12 weeks
Systemic inflammation measured as high sensitive C reactive protein (hs-CRP) in blood at baseline and at week 12.
Gastrointestinal symptoms
Plazo: from baseline to 12 weeks
Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS).The GSRS is a 15 items questionnaire combined into five symptom clusters i.e Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.(GSRS) at baseline and at week 12.
health-related quality of life
Plazo: from baseline to 12 weeks
Quality of life as assessed by short form survey-36 (SF-36) questionnaires at baseline and at week 12.
The SF-36 is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). These outcomes will be grouped as a physical component summary and a mental component summary. The norm data is 0-100, and the health-related quality of life increases as the scores increase.
Stool consistency
Plazo: from baseline to 12 weeks
Stool consistency (Bristol Stool Scale), as reported in the daily eDiary app (at baseline and week 12).
Participants will identify each bowel movement 'type' using the Bristol Stool Scale (Type 1 = hard stool difficult to pass \[classified as severe constipation\]; Type 7 = watery, entirely liquid stool \[classified as severe diarrhea\]). 'Normal' stool is considered to be Types 3 and 4; and Types 6 and 7 would be considered to suggest mild and severe diarrhea, respectively.
Stool frequency
Plazo: from baseline to 12 weeks
Stool frequency, as reported in the daily eDiary app (at baseline and week 12).
Systemic vitamin status
Plazo: from baseline to 12 weeks
The concentration of B vitamins in blood at baseline
Faecal physiological pH and redox
Plazo: from baseline to 12 weeks
Faecal physiological parameters measured as pH and redox potential at baseline and at week 12.
Faecal microbial composition at week 4
Plazo: from baseline to 4 weeks
Faecal microbial composition at phylum, genus, and species levels, as measured by metagenomic based profiles at baseline and at week 4.
Alpha diversity at week 4
Plazo: baseline to Week 4.
Alpha diversity measured as Observed, Chao Index, Simpson Index, Shannon Index at baseline and Week 4.
Beta diversity at week 4
Plazo: week 0 to week 4
Beta diversity (Jaccard, Bray Curtis, Aitchson) at baseline and week 4
Microbial metabolites at week 4
Plazo: from baseline to 4 weeks
Faecal microbial metabolites measured as total short-chain fatty acid content at baseline and week 4.
Acetate, Propionate and Butyrate at week 4
Plazo: week 0 to week 4
Acetate, Propionate and Butyrate SCFAs (µmol/g) at baseline and week 4.
Otras medidas
Skin barrier integrity
Plazo: from baseline to 12 weeks
Skin barrier integrity measured as trans-epidermal water loss (TEWL) g/m²/h at baseline and at week 12.
Skin hydration
Plazo: from baseline to 12 weeks
Skin hydration measured using corneometry from 0 (no water at all) to 120 (on water) at baseline and at week 12.
Objective skin-health
Plazo: from baseline to 12 weeks
Objective skin-health assessment completed by the participant using Likert scale (from not at al to very much) at baseline and at week 12.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, CorkCork, IrelandEstado desconocido
Equipo y fechas
- Patrocinador principal
- dsm-firmenich Switzerland AG
- Inicio del estudio
- 12 dic 2022 Real
- Finalización primaria
- 6 jul 2023 Real
- Finalización del estudio
- 6 jul 2023 Real
- Primera publicación
- 7 abr 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026