Investigating the Impact of Vitamin D Biofortified Tomatoes on Serum Levels of 25(OH)D

NCT07142759 | Enrolling By Invitation

• 2 other identifiers: QIB03/2024IRAS 349335
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

In the UK, vitamin D deficiency occurs frequently especially during the winter months. Vitamin D biofortified tomatoes have been developed using precision breeding technique by researchers at John Innes Centre. Biofortification uses crop breeding to increase the nutritional value of crops. The goal of the ViTaL-D study is to examine whether the vitamin D biofortified tomatoes when eaten as a soup can increase blood levels of vitamin D in men and women with vitamin D deficiency. Additionally, researchers will learn if the tomato soups are feasible and safe to eat everyday. The main questions the study aims to answer are:

• Does vitamin D biofortified tomatoes increase vitamin D levels in men and women with low blood levels of vitamin D?
• Is consuming vitamin D biofortified tomatoes safe and easy to eat everyday as a soup? Researchers will compare how four types of tomato soup increase blood vitamin D levels. The four types of soup are:
• Soup with vitamin D biofortified tomatoes
• Soup with provitamin D biofortified tomatoes
• Soup with store-bought tomatoes not containing vitamin D
• Soup with store-bought tomatoes with added vitamin D Participants will:
• Eat one of the four types of tomato soup every day for 21 days.
• Visit the clinic once every 7 days after a 12 hour fast for body measurements, tests, and surveys.
• Keep a daily diary when soups are eaten and when time is spent outside.

Conditions

Vitamin D Insufficiency

Keywords

tomato soup; precision breeding; biofortification; vitamin D; 25-hydroxy vitamin D (25[OH]D); dietary intervention

Outcome Measures

Primary Outcomes (9)

• Change in plasma lycopene and beta carotene to assess adherence

  Fasting plasma total carotenoids and total lycopene

  Day 0 and Day 21

• Differences in soup acceptability using sensory evaluation questionnaires as a measure of adherence

  Soup acceptability will be measured using a 9-point hedonic scale and 5 point Just-about-Right scale

  Screening visit (Day -60 to -1), Day 1, and Day 21

• Assess changes in eating pattern due to daily consumption of soup

  VioScreen Food frequency questionnaire

  Day 0 and Day 21

• Changes in serum 25-hydroxy vitamin D (25(OH)D) to monitor safety

  Fasting serum 25(OH)D levels

  Day 0 and Day 21

• Changes in serum electrolytes, calcium and phosphorous to monitor safety

  Fasting serum electrolytes, calcium and phosphorus

  Day 0 and Day 21

• Change in parathyroid hormone to assess safety

  Fasting plasma parathyroid hormone

  Day 0 and Day 21

• Assess change in bone turnover biomarkers on serum 25(OH)D levels

  Fasting serum procollagen Type 1 N-Terminal Propeptide and Collagen Type 1 Cross-Linked C Telopeptide (P1NP and CTx)

  Day 0 and Day 21

• Measure changes in sunlight exposure

  Quantify sunlight exposure using Outdoor Skin Assessment, Sun-a-Wear UV tracker UV (duration UV exposure and UV Index)

  Day 0 and Day 21

• Measure changes in physical activity

  Physical activity will be measured using the International Physical Activity Questionnaire - short version

  Day 0 and Day 21

Secondary Outcomes (4)

• Treatment effects of daily tomato soup consumption on vitamin D3 or its precursor (7-DHC) on serum 25(OH)D, PTH, cholesterol

  Day 21

• Quantify differences in vitamin D metabolites

  Day 0 and Day 21

• Changes in the quantity of vitamin D and their binding proteins in saliva

  Day 0 and Day 21

• Correlate salivary vitamin D and salivary vitamin D binding protein and serum 25(OH)D levels

  Day 0 and Day 21

Study Arms (4)

Soup with Precision Bred Tomatoes (Provitamin D-rich, No UV-Treatment)

EXPERIMENTAL

Soup made with precision bred (gene-edited) tomatoes that have been engineered to accumulate 7-dehydrocholesterol (7-DHC) also known as provitamin D is a precursor of vitamin D3. These tomatoes have undergone CRISPR-Cas9 gene editing to allow the accumulation of 7-DHC in the tomatoes and remains to be rich in 7-DHC when protected from UV light.

Other: Precision Bred Provitamin D-rich Tomato Soup

Soup with Precision Bred Tomatoes (Vitamin D-rich, UV-Treated)

EXPERIMENTAL

Soup is made with the same precision bred tomatoes, but in this case, the tomatoes have been treated with ultraviolet (UV) light to convert the accumulated 7-DHC into vitamin D3. UV exposure mimics the natural process by which human skin synthesizes vitamin D3 from sunlight.

Other: Precision Bred Vitamin D-rich Tomato Soup

Soup Made with Wild-Type (Store-bought) Tomatoes

PLACEBO COMPARATOR

In this soup, store-bought (wild-type) tomatoes contain negligible amounts of 7-DHC and no vitamin D3.

Other: Wild-type (store-bought) Tomato Soup

Soup Made with Wild-Type (Store-bought) Tomatoes with Vitamin D3 Supplement

ACTIVE COMPARATOR

In this soup, store-bought (wild-type) tomatoes are used and supplemented with vitamin D3 (lanolin).

Other: Wild-type (store-bought) Tomato with vitamin D supplementation Soup

Interventions

Precision Bred Provitamin D-rich Tomato Soup OTHER

Participants will consume one tomato soup every day for 21 days as part of their normal diet.

Soup with Precision Bred Tomatoes (Provitamin D-rich, No UV-Treatment)

Precision Bred Vitamin D-rich Tomato Soup OTHER

Participants will consume one tomato soup everyday for 21-days as part of their normal diet.

Soup with Precision Bred Tomatoes (Vitamin D-rich, UV-Treated)

Wild-type (store-bought) Tomato Soup OTHER

Participants will consume one tomato soup every day for 21 days as part of their normal diet.

Soup Made with Wild-Type (Store-bought) Tomatoes

Wild-type (store-bought) Tomato with vitamin D supplementation Soup OTHER

Participants will consume one tomato soup everyday for 21 days as part of their normal diet.

Soup Made with Wild-Type (Store-bought) Tomatoes with Vitamin D3 Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing to eat a tomato soup daily for 21 days.
• Have access to a smartphone or tablet device and internet access.
• Be at least 18 years old
• Be able to understand the study and provide informed consent
• Have serum 25-hydroxyvitamin D (25\[OH\]D) levels between 25-40 nmol/L
• Body Mass Index 18.5 to 35 kg/m2
• Live within 40 miles of the Quadram Institute.

You may not qualify if:

• Have a known allergy or intolerance to tomatoes or to any of the soup components (tomatoes, milk, wheat, lanolin are the major allergens, but a detailed list is in Annex 16) of the test soups.
• Currently undergoing treatment or on medications for hypo/hypercalcaemia, hypo/hyperparathyroidism, kidney stones, or bone diseases.
• Have anaemia, immunocompromised or viral infections that may compromise immunity. This will be assessed on a case-by-case basis by QI medical advisor.
• Have any acute or chronic illnesses that affects the outcome of the study such as a gastrointestinal disorder. This will be assessed on a case-by-case basis by Quadram Institute medical advisor.
• Have just started taking or changed dose of vitamin D supplement in the month prior to the start of the intervention or at any point during the intervention, or are regularly taking more than 400 International Units (IU) of vitamin D.
• Are on a routine regimen of vitamin D supplementation over 400 IU who have begun supplementation or had changes in their dose a month prior or have changes during the course of the study.
• Are on any medication regimen that may alter vitamin D absorption they are as follow but not limited to; bile acid sequestrants, hormone replacement therapy, thiazides, calcium channel blockers, isoniazid, anti-seizure medications, and antacids.
• Any dietary restriction that prevents the consumption of the study soups or follow a diet programme which requires fasting for multiple days (soups are not suitable for vegans).
• Have abnormally low or high blood pressure (i.e. ≤90/60, ≥160/100).
• Plan to become pregnant during the study duration, pregnant or breastfeeding.
• Are currently taking part in an intervention study.
• Are a registered blood donor and have donated a large quantity of blood within the last 6 weeks. Registered blood donors should abstain from blood donations for the duration of the study.
• Are unable to give written or verbal informed consent
• Unable to provide your GP contact details.
• Fall under the line management structure or live in the same household with any of the research team, or the QIB Human Studies Team

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• University of Surrey: collaborator
• John Innes Centre: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• NIHR Norfolk Clinical Research Facility: collaborator

Study Sites (1)

Quadram Institute Bioscience

Norwich, NR4 7UQ, United Kingdom

Location

Study Officials

• Martin Warren, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

GB (1)