An interventional study of Riboflavin in Quality of Life, sponsored by DSM Nutritional Products, Inc.. Completed at 1 site in Ireland. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by DSM Nutritional Products, Inc. · Not applicable, Interventional, and Basic science
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)
DSM Nutritional Products, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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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Daily dose of 1.4 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks
Dietary Supplement: Riboflavin
Daily dose of 10 mg of Vitamin B2 (Riboflavin) once a day for 12 weeks
Dietary Supplement: Riboflavin
Daily dose of 75 mg Vitamin B2 (Riboflavin) once a day for 12 weeks
Dietary Supplement: Riboflavin
One capsule of 570 mg (consisting of microcrystalline cellulose) once a day for 12 weeks
Dietary Supplement: Riboflavin
Colon delivered vitamin B2 (Riboflavin) for 12 weeks
Faecal microbial composition and diversity
To assess the changes of faecal microbial composition and diversity from baseline to 12 weeks supplementation of three different doses of colon delivered vitamin B2 to compare the changes to placebo. levels, and alpha and beta diversity indices at the genus and species level as measured by metagenomic based profiles at baseline and at week 12
Time frame: from baseline to 12 weeks
Faecal microbial metabolites fatty acid content at baseline and week 12
Faecal microbial metabolites measured as short-chain fatty acid content at baseline and week 12
Time frame: Intestinal inflammation as assessed by faecal calprotectin at baseline and at week 12
Intestinal inflammation
Intestinal barrier integrity as assessed by sCD14 at baseline and at week 12
Time frame: from baseline to 12 weeks
Intestinal barrier integrity
Oxidative stress level measured as free thiol content in blood at baseline and at week 12
Time frame: from baseline to 12 weeks
Oxidative stress in blood
Oxidative stress level measured as free thiol content in blood at baseline and at week 12
Time frame: from baseline to 12 weeks
Inflammatory status in blood
Systemic inflammation measured as high sensitive C reactive protein (hs-CRP) in blood at baseline and at week 12.
Time frame: from baseline to 12 weeks
Gastrointestinal symptoms
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.
Time frame: from baseline to 12 weeks
health-related quality of life
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.
Time frame: from baseline to 12 weeks
Stool consistency
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.
Time frame: from baseline to 12 weeks
Stool frequency
Stool frequency, as reported in the daily eDiary app (at baseline and week 12).
Time frame: from baseline to 12 weeks
Systemic vitamin status
The concentration of B vitamins in blood at baseline
Time frame: from baseline to 12 weeks
Faecal physiological pH
Faecal physiological parameters measured as pH potential at baseline and at week 12.
Time frame: from baseline to 12 weeks
Faecal microbial composition and diversity at week 4
Faecal microbial composition at phylum, genus, and species levels, and alpha and beta diversity indices at the genus and species level as measured by metagenomic based profiles at baseline and at week 4.
Time frame: from baseline to 4 weeks
Microbial metabolites at week 4
Faecal microbial metabolites measured as short-chain fatty acid content at baseline and week 4.
Time frame: from baseline to 4 weeks
Skin barrier integrity
Skin barrier integrity measured as trans-epidermal water loss (TEWL) g/m²/h at baseline and at week 12.
Time frame: from baseline to 12 weeks
Skin hydration
Skin hydration measured using corneometry from 0 (no water at all) to 120 (on water) at baseline and at week 12.
Time frame: from baseline to 12 weeks
Objective skin-health
Objective skin-health assessment completed by the participant using Likert scale (from not at al to very much) at baseline and at week 12.
Time frame: from baseline to 12 weeks
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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DSM Nutritional Products, Inc.