NCT07388121

Brief Summary

The aim of this dietary intervention study is to explore how vitamin C affects the bacteria that live in our gut. Vitamins are essential nutrients found in fruits and vegetables. Our bodies cannot make them on their own, but we need them to function correctly. Vitamins play various roles, including supporting the immune system and assisting with energy production. Some vitamins in our diet can reach the large intestine, where they may be used by gut bacteria to promote their growth. In this study, we aim to investigate how our gut bacteria interact with vitamin C and how this interaction affects their growth and activity. For this study, participants will follow their habitual diet for one-week (run-in period), followed by two consecutive two-week supplementation periods in which they will first take a moderate dose (200 mg/day) and then a high-dose (1000 mg/day) of vitamin C. A final one-week period follow up period will involve a return to their habitual diet. Faecal, blood and urine samples will be collected at the start and end of each supplementation period to explore changes in gut microbiota composition, activity and markers of inflammation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Nov 2025Jul 2026

Study Start

First participant enrolled

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 4, 2026

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

December 18, 2025

Last Update Submit

January 30, 2026

Conditions

Keywords

vitamin Cgut microbiotaSCFA

Outcome Measures

Primary Outcomes (3)

  • Butyrate (Short Chain Fatty Acid)

    Quantified in stool samples using Gas Chromatography

    Baseline (Visit 1), Week 1 (Visit 2), Week 3 (Visit 3), Week 5 (Visit 4) and Week 6 (Visit 5)

  • Short Chain Fatty Acids i.e. acetate, propionate, butyrate, total

    Quantified in stool samples using Gas Chromatography

    Baseline (Visit 1), Week 1 (Visit 2), Week 3 (Visit 3), Week 5 (Visit 4) and Week 6 (Visit 5)

  • Stool microbiota composition analysis

    16S rRNA gene amplicon sequencing from faecal DNA extracts

    Baseline (Visit 1), Week 1 (Visit 2), Week 3 (Visit 3), Week 5 (Visit 4) and Week 6 (Visit 5)

Secondary Outcomes (3)

  • Stool pH

    Baseline (Visit 1), Week 1 (Visit 2), Week 3 (Visit 3), Week 5 (Visit 4) and Week 6 (Visit 5)

  • Vitamin C in plasma

    Week 1 (Visit 2), Week 3 (Visit 3), and Week 5 (Visit 4)

  • Inflammatory markers

    Week 1 (Visit 2), Week 3 (Visit 3), and Week 5 (Visit 4)

Other Outcomes (1)

  • Gut barrier function markers

    Week 1 (Visit 2), Week 3 (Visit 3), and Week 5 (Visit 4)

Study Arms (1)

Sequential vitamin C intervention

EXPERIMENTAL

In this single-arm, sequential dietary intervention study, participants will follow their normal habitual diet for one week (run-in period) and then receive two different doses of vitamin C tablets over two consecutive 14-day periods: a moderate dose of 200 mg/day during the first period (2 weeks) and a high dose of 1000 mg/day during the second period (another 2 weeks). The study also includes one week post intervention follow up period (habitual diet) after the high vitamin C dose where participants return to their habitual diet without vitamin C supplementation

Dietary Supplement: Moderate Vitamin C dose (200 mg)Dietary Supplement: High-dose vitamin C supplementation (1000 mg)Other: Habitual diet (run in period)

Interventions

200 mg of vitamin C provided as a chewable tablet, taken orally daily for two weeks

Sequential vitamin C intervention

1000 mg of Vitamin C provided as a chewable tablet, taken orally daily for two weeks

Sequential vitamin C intervention

this is a run-in period where participants consume their habitual diet for one week

Sequential vitamin C intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals aged 18-65 years with a BMI between 18.5-35 Kg/m2
  • Self-reported good health with no chronic conditions requiring regular medical care
  • Willing to provide blood, urine, and stool samples at multiple time points

You may not qualify if:

  • Aged \<18 or \>65 years
  • Smoking
  • Chronic illness requiring regular medication or GP visits
  • Current or recent medication affecting gut transit or digestion
  • Major gastrointestinal surgery
  • Pregnant or breastfeeding
  • Regular use of pre/probiotics, vitamins, or minerals (unless willing to discontinue 2-4 weeks prior)
  • Antibiotics in past 3 months
  • Weight change \>±2 kg in past month
  • Participation in other research likely to interfere with this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Lister Building, Glasgow Royal Infirmary, 10-16 Alexandra Parade, G31 2ER

Glasgow, G31 2ER, United Kingdom

RECRUITING

MeSH Terms

Interventions

Jogging

Intervention Hierarchy (Ancestors)

RunningLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Athanasios Koutsos, PhD

    Human Nutrition, School of Medicine, College of Medical, Veterinary, and Life Sciences, University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Human Nutrition

Study Record Dates

First Submitted

December 18, 2025

First Posted

February 4, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 4, 2026

Record last verified: 2025-11

Locations