NCT02982525

Brief Summary

A significant proportion of the United Kingdom population have inadequate levels of vitamin D in their blood. Vitamin D is a fat-soluble vitamin that is essential for the growth and maintenance of healthy bones through increasing dietary calcium absorption within the body. A low vitamin D status has also been associated with other diseases such as osteoporosis, cancer (especially colorectal cancer), cardiovascular disease and type 1 diabetes. Our skin is able to synthesise vitamin D upon exposure to sunlight in summer. If exposure to sunlight is limited, then a dietary supply of vitamin D becomes essential. However, very few foods contain vitamin D. Among the best dietary sources of vitamin D are oily fish (including salmon, mackerel, herring and trout) and fish oils. Recently, the investigators found that certain shellfish, especially mussels, contain significant amounts of a metabolite of vitamin D, 25(OH)D3. Consumption of this metabolite, as a supplement, has already been shown to improve vitamin D status in humans. Whether consumption of mussels improves vitamin D status is unknown. In this study the investigators will be looking at whether consumption of 1, 2 or 3 portions of mussels per week for 12 weeks increases vitamin D status in healthy people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

December 1, 2016

Last Update Submit

October 8, 2019

Conditions

Cardiovascular Disease

Keywords

MusselsDietary InterventionLong-term interventionVitamin D statusSeleniumIodineVitamin B12Omega-3 index

Outcome Measures

Primary Outcomes (1)

  • Change in Vitamin D status

    Serum Vitamin D status will be assessed by measuring plasma 25-hydroxy vitamin D3 by Liquid Chromatography/Mass Spectrometry, the gold standard method

    At baseline and after 12 weeks mussel supplementation

Secondary Outcomes (2)

  • Vitamin B12 status

    At baseline and after 12 weeks mussel supplementation

  • Change in omega-3 index

    At baseline and after 12 weeks mussel supplementation

Study Arms (4)

No Mussels

EXPERIMENTAL

The control group will continue to consume their normal habitual diet

Dietary Supplement: No Mussels

One mussel portion

EXPERIMENTAL

One 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption.

Dietary Supplement: One mussel portion

Two mussel portions

EXPERIMENTAL

Two 75g portions of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption

Dietary Supplement: Two mussel portions

Three mussel portions

EXPERIMENTAL

Three 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption

Dietary Supplement: Three mussel portions

Interventions

No MusselsDIETARY_SUPPLEMENT

Habitual diet only

No Mussels
One mussel portionDIETARY_SUPPLEMENT

1 x 75g mussel portions provided per week

One mussel portion
Two mussel portionsDIETARY_SUPPLEMENT

2 x 75g mussel portions provided per week

Two mussel portions
Three mussel portionsDIETARY_SUPPLEMENT

3 x 75g mussel portions provided per week

Three mussel portions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ranging from 18-35
  • Not having any food allergies
  • Not taking any fish oil or certain nutritional / vitamin supplements
  • Non-smoker

You may not qualify if:

  • Regularly take aspirin or aspirin-containing drugs
  • Taking drugs or herbal medicines known to alter the haemostatic system in general
  • Taking certain dietary supplements / multivitamin tablets
  • Anyone suffering from diabetes, hypertension, renal, hepatic or haematological disease
  • Heart / circulation problems
  • Eating disorders
  • Smoking
  • Any existing shellfish allergy
  • Having difficult venous access or problems giving blood in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen, The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Baukje De Roos, PhD

    University of Aberdeen, The Rowett Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

November 28, 2016

Primary Completion

April 20, 2017

Study Completion

December 31, 2018

Last Updated

October 9, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)