Cardiovascular DiseaseMusselNCT02982525
Mussel Intake and Vitamin D Status in Humans
A study testing No Mussels, One mussel portion and Two mussel portions in people with Cardiovascular Disease, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- No Mussels, One mussel portion and Two mussel portions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Nov 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ranging from 18-35
- Not having any food allergies
- Not taking any fish oil or certain nutritional / vitamin supplements
- Non-smoker
Who cannot join
- 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
Show all 9Show fewer
- Smoking
- Any existing shellfish allergy
- Having difficult venous access or problems giving blood in the past
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen, The Rowett Institute
Aberdeen, AB25 2ZD
About this study
Official title: Effect of Mussel Intake on Vitamin D Status Study
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.
Read the detailed description
Vitamin D, the main forms being vitamin D2 (ergocalciferol) and D3 (cholecalciferol), is a group of fat-soluble secosteroids which are synthesised from ergosterol in fungi and yeast, or from 7-dehydrocholesterol in humans, animals including fish and plants including microalgae, upon exposure to UV radiation. The metabolically inert vitamin D3 is then converted into 25-hydroxy D3 (25(OH)D3) and subsequently into 1α,25-dihydroxy D3 (1,25(OH)2D3).
A significant proportion of the global population have inadequate vitamin D levels - as defined by a plasma 25(OH)D concentration of <25 nM, - a level where the risk of poor musculoskeletal health appears to increase, which is especially apparent in older children, younger adults, older institutionalised individuals and infants from black and ethnic minority groups. Data from the NDNS and other studies suggest that between 29 and 54% of various population groups in the UK have a serum 25(OH)D concentration < 25 nmol/L in the winter. However, summer synthesis of vitamin D, facilitating maintenance of winter serum 25(OH)D concentration ≥ 25 nmol/L is clearly not occurring for many in the UK population (Consultation on draft SACN Vitamin D and Health report). If there is inadequate vitamin D3 synthesis within the skin, generally caused by limited exposure to sunlight, then a dietary supply of vitamin D becomes essential.
Overall 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, providing up to 20g of vitamin D per 100 g. Lower amounts of vitamin D are present in red meat, liver and egg yolks (approximately 1-5g/100 g). Vitamin D in these foods and in fish is primarily in the form of vitamin D3 and its metabolite 25(OH)D3.
Recently, investigators have found that certain shellfish, especially mussels, contain significant amounts of 25(OH)D3, ranging from 0.7 to 9.9 µg/100 g wet weight. Thus far, food composition databases give either very low or no values for levels of vitamin D in shellfish. The amount of vitamin D3 in mussels is either reported to be below the detection limit, or is not analysed, in mussels in the food database analysis. The importance of finding 25(OH)D3 rather than vitamin D3 in mussels is illustrated by the fact that this metabolite is considered 5 times more effective in raising serum 25(OH)D3 levels in humans, and thus vitamin D status, than vitamin D3 itself. An interesting parallel with meat appears. Meat contains little native vitamin D but as better measurement techniques detected more metabolites of vitamin D, which were considered to be more potent, these have been added to food composition tables. Indeed, the apparent increase in vitamin D intakes in the British household food data, in 1995 and 1996, is a direct result of including the potency factor for meat. Taking account of this potency factor, mussels could provide up to 50g of vitamin D per 100g. Whether consumption of mussels improves vitamin D status in humans is however, not known.
According to exploratory meta-regression analyses of RCT data in a number of European (51-60°N) winter-based, dose-related RCTs which used supplemental doses of vitamin D between 0-20 μg/d, have reported vitamin D-serum 25(OH)D concentration slope estimates of 1.55-2.43 nmol/L increment per 1 μg vitamin D (Consultation on draft SACN Vitamin D and Health report). Thus 1, 2 and 3 portions of mussels per week, providing the equivalent of approx. 2.7, 5.4 and 8.0 mg/day (including the potency factor of 5) may increase serum levels of 25(OH)D3 by 4.2-6.6 nmol/L for 1 portion of mussels per week, 8.4-13.1 nmol/L for 2 portions per week or 12.4-19.4 nmol/L for 3 portions of mussels per week
- Conditions
- Cardiovascular Disease
- Being tested
- No Mussels, One mussel portion, Two mussel portions, Three mussel portions
- Keywords
- Mussels, Dietary Intervention, Long-term intervention, Vitamin D status, Selenium, Iodine, Vitamin B12, Omega-3 index
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No MusselsDietary supplement
Habitual diet only
One mussel portionDietary supplement
1 x 75g mussel portions provided per week
Two mussel portionsDietary supplement
2 x 75g mussel portions provided per week
Three mussel portionsDietary supplement
3 x 75g mussel portions provided per week
| Study group | Role | What they receive |
|---|---|---|
| No Mussels | Experimental | The control group will continue to consume their normal habitual diet Receives: 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. Receives: 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 Receives: 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 Receives: Dietary Supplement: Three mussel portions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and after 12 weeks mussel supplementation
Secondary outcomes (2)
Vitamin B12 status
Vitamin B12 status will be measured in plasma using the microbiological assay using L. Delbrueckii. Lactis
Measured: At baseline and after 12 weeks mussel supplementation
Change in omega-3 index
The Omega-3 index will be measured by Gas Chromatography-Mass Spectrometry. An optimal target level of the Omega-3 index is 8%, and an undesirable level is less than 4%, with 4-8% being an intermediate-risk zone.
Measured: At baseline and after 12 weeks mussel supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start28 Nov 2016
- Primary completion20 Apr 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baukje De Roos, PhD, Principal investigator, University of Aberdeen, The Rowett Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982525
- Sponsor's protocol ID
- 2016/RINH/7
- Acronym
- Mussel
- Status last verified
- Oct 2019
- First submitted
- 1 Dec 2016
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mussel Intake on Vitamin D Status Study
- ClinicalTrials.gov ID
- NCT02982525
- Acronym / sponsor ID
- Mussel / 2016/RINH/7
- Conditions
- Cardiovascular Disease
- Keywords
- Mussels, Dietary Intervention, Long-term intervention, Vitamin D status, Selenium, Iodine, Vitamin B12, Omega-3 index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vitamin D, the main forms being vitamin D2 (ergocalciferol) and D3 (cholecalciferol), is a group of fat-soluble secosteroids which are synthesised from ergosterol in fungi and yeast, or from 7-dehydrocholesterol in humans, animals including fish and plants including microalgae, upon exposure to UV radiation. The metabolically inert vitamin D3 is then converted into 25-hydroxy D3 (25(OH)D3) and subsequently into 1α,25-dihydroxy D3 (1,25(OH)2D3).
A significant proportion of the global population have inadequate vitamin D levels - as defined by a plasma 25(OH)D concentration of <25 nM, - a level where the risk of poor musculoskeletal health appears to increase, which is especially apparent in older children, younger adults, older institutionalised individuals and infants from black and ethnic minority groups. Data from the NDNS and other studies suggest that between 29 and 54% of various population groups in the UK have a serum 25(OH)D concentration < 25 nmol/L in the winter. However, summer synthesis of vitamin D, facilitating maintenance of winter serum 25(OH)D concentration ≥ 25 nmol/L is clearly not occurring for many in the UK population (Consultation on draft SACN Vitamin D and Health report). If there is inadequate vitamin D3 synthesis within the skin, generally caused by limited exposure to sunlight, then a dietary supply of vitamin D becomes essential.
Overall 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, providing up to 20g of vitamin D per 100 g. Lower amounts of vitamin D are present in red meat, liver and egg yolks (approximately 1-5g/100 g). Vitamin D in these foods and in fish is primarily in the form of vitamin D3 and its metabolite 25(OH)D3.
Recently, investigators have found that certain shellfish, especially mussels, contain significant amounts of 25(OH)D3, ranging from 0.7 to 9.9 µg/100 g wet weight. Thus far, food composition databases give either very low or no values for levels of vitamin D in shellfish. The amount of vitamin D3 in mussels is either reported to be below the detection limit, or is not analysed, in mussels in the food database analysis. The importance of finding 25(OH)D3 rather than vitamin D3 in mussels is illustrated by the fact that this metabolite is considered 5 times more effective in raising serum 25(OH)D3 levels in humans, and thus vitamin D status, than vitamin D3 itself. An interesting parallel with meat appears. Meat contains little native vitamin D but as better measurement techniques detected more metabolites of vitamin D, which were considered to be more potent, these have been added to food composition tables. Indeed, the apparent increase in vitamin D intakes in the British household food data, in 1995 and 1996, is a direct result of including the potency factor for meat. Taking account of this potency factor, mussels could provide up to 50g of vitamin D per 100g. Whether consumption of mussels improves vitamin D status in humans is however, not known.
According to exploratory meta-regression analyses of RCT data in a number of European (51-60°N) winter-based, dose-related RCTs which used supplemental doses of vitamin D between 0-20 μg/d, have reported vitamin D-serum 25(OH)D concentration slope estimates of 1.55-2.43 nmol/L increment per 1 μg vitamin D (Consultation on draft SACN Vitamin D and Health report). Thus 1, 2 and 3 portions of mussels per week, providing the equivalent of approx. 2.7, 5.4 and 8.0 mg/day (including the potency factor of 5) may increase serum levels of 25(OH)D3 by 4.2-6.6 nmol/L for 1 portion of mussels per week, 8.4-13.1 nmol/L for 2 portions per week or 12.4-19.4 nmol/L for 3 portions of mussels per week
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Mussels | Experimental | Dietary Supplement: No MusselsThe control group will continue to consume their normal habitual diet |
| One mussel portion | Experimental | Dietary Supplement: One mussel portionOne 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption. |
| Two mussel portions | Experimental | Dietary Supplement: Two mussel portionsTwo 75g portions of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption |
| Three mussel portions | Experimental | Dietary Supplement: Three mussel portionsThree 75g portion of Scottish mussels provided per week for 12 weeks on top of normal habitual shellfish consumption |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ranging from 18-35
- Not having any food allergies
- Not taking any fish oil or certain nutritional / vitamin supplements
- Non-smoker
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No MusselsHabitual diet only | Dietary supplement | No Mussels |
| One mussel portion1 x 75g mussel portions provided per week | Dietary supplement | One mussel portion |
| Two mussel portions2 x 75g mussel portions provided per week | Dietary supplement | Two mussel portions |
| Three mussel portions3 x 75g mussel portions provided per week | Dietary supplement | Three mussel portions |
Primary outcome
Change in Vitamin D status
Time frame: At baseline and after 12 weeks mussel supplementation
Serum Vitamin D status will be assessed by measuring plasma 25-hydroxy vitamin D3 by Liquid Chromatography/Mass Spectrometry, the gold standard method
2 secondary outcomes
Vitamin B12 status
Time frame: At baseline and after 12 weeks mussel supplementation
Change in omega-3 index
Time frame: At baseline and after 12 weeks mussel supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baukje De Roos, PhD principal investigator
University of Aberdeen, The Rowett Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Mussels, One mussel portion and Two mussel portions in people with Cardiovascular Disease, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vitamin D status (time frame: At baseline and after 12 weeks mussel supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.