Bioavailability of Orally Ingested Vitamin C (ABBA)

Investigating the Oral Bioavailability of Vitamin C Administered Using Phosphycell™ Technology - a Phosphatidylcholine-lipid Encapsulation Technology.

The purpose of this study is to determine if crystalline vitamin C supplementation can acutely increase skeletal muscle vitamin C concentrations and if this can be potentiated by administering vitamin C using Phosphycell™ Technology - a phosphatidylcholine-lipid encapsulation technology.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Crystalline vitamin C; Dietary supplement: Phosphatidylcholine-lipid encapsulated vitamin C

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom Jameson; Phone Number: +44 (0) 1392 722157; Email: T.Jameson@exeter.ac.uk

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX1 2LU
      • Recruiting
      • Sport and Health Sciences
      • Contact: Tom Jameson; Email: t.jameson@exeter.ac.uk
      • Principal Investigator: Tom Jameson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index (BMI) 18.5 - 30 kg/m2
• Age 18 - 40
• Non-smoker

Exclusion Criteria:

• Body mass index (BMI) < 18.5 or > 30 kg/m2
• Age < 18 or > 40
• Smoking
• Cardiovascular disease
• Hypertension (≥ 140/90 mmHg)
• Metabolic disease
• Medications known to affect vitamin C metabolism
• A known vitamin C deficiency
• Less than 2 hours per week of physical activity or following a structured exercise training program.
• Routine use of vitamin supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Crystalline vitamin C supplementation; 1000 mg of vitamin C ingested in crystalline form	Dietary supplement: Crystalline vitamin C; Ingesting 1000 mg of vitamin C in crystalline form
EXPERIMENTAL: Phosphatidylcholine-lipid encapsulated vitamin C supplementation; 1000 mg of vitamin C ingested in phosphatidylcholine-lipid encapsulated form	Dietary supplement: Phosphatidylcholine-lipid encapsulated vitamin C; Ingesting 1000 mg of vitamin C in phosphatidylcholine-lipid encapsulated form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle vitamin C concentrations	Skeletal muscle vitamin C concentrations 6 hours after vitamin C ingestion will be measured using HPLC and compared to baseline	6 hours after vitamin C ingestion
Skeletal muscle vitamin C concentrations	Skeletal muscle vitamin C concentrations 12 hours after vitamin C ingestion will be measured using HPLC and compared to baseline and 6 hours after vitamin C ingestion	12 hours after vitamin C ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood plasma vitamin C concentrations	Blood plasma vitamin C concentrations will be measured using HPLC during the 24 hour post vitamin C ingestion period	24 hours after vitamin C ingestion
White blood cell vitamin C concentrations	White blood cell vitamin C concentrations will be measured 6 hours after vitamin C ingestion using HPLC and compared to baseline	6 hours after vitamin C ingestion
White blood cell vitamin C concentrations	White blood cell vitamin C concentrations will be measured 24 hours after vitamin C ingestion using HPLC and compared to baseline and 3 hours post vitamin C ingestion	24 hours after vitamin C ingestion
Cardiovascular function	Cardiovascular function will be measuring using a finger plethysmograph during the 24 hour post vitamin C ingestion period	24 hours after vitamin C ingestion

Collaborators and Investigators

• Sponsor: University of Exeter

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2021
• Primary Completion (ANTICIPATED): November 26, 2022
• Study Completion (ANTICIPATED): November 26, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (ACTUAL): January 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• Other Study ID Numbers: 21-10-20-B-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No