Effect of vitaminD3 or 25(OH)D3 Fortified Dairy on Vitmain D Status and CVD Risk Markers

NCT02535910 | Unknown DMC

• 1 other identifier: VitD
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the acute effect of consuming milk and butter fortified with either vitamin D3 or 25 (OH) D3 on serum/plasma vitamin D status in humans. In addition, the effect of vitamin D3 or 25 (OH) D3 in milk and butter on certain CVD risk markers and cognitive function will be examined.

Conditions

Hypovitaminosis D; Cardiovascular Diseases

Keywords

vitamin D3; 25(OH)D3; vitamin D status; risk factors of cardiovascular diease

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the concentrations of vitamin D3, 25(OH)D3, 1, 25(OH)2D3 of the blood

  Acute study: measured at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour

• Change from baseline in the concentrations of vitamin D3 and 25(OH)D3 of the chylomicron

  Acute study: measured at 0 (baseline), 3, 6, 8 hour

Secondary Outcomes (8)

• change from baseline in vascular reactivity measured by Endo-PAT

  Acute study: measured at 0 (baseline) and the 24 hour

• change from baseline in vascular reactivity measured by digital volume pulse (DVP)

  Acute study: measured at 0 (baseline), 120, 240, 360, 480 min and 24 hour

• change from baseline in plasma lipids (primarily triacylglycerol, apolipoprotein B, apolipoprotein B-48, apolipoprotien B-100, total-cholesterol, HDL-cholesterol, non-esterified fatty acids)

  from 0 to 24 hour, but different measured time points for diferent lipids

• change from baseline in markers of insulin resistance (glucose and insulin)

  Acute study: measured at 0, 30, 60, 90, 120, 180, 240, 300, 360, 420, 480 min and 24 hour

• change from baseline in nitric oxide

  Acute study: measured at 0, 60, 120, 240, 360, 480 min and 24 hour

Study Arms (3)

breakfast rich in vitamin D3

EXPERIMENTAL

subjects are asked to consume a breakfast with (20µg) vitamin D3 fortified milk and butter

Dietary Supplement: vitamin D3

breakfast rich in 25(OH) D3

EXPERIMENTAL

subjects are asked to consume a breakfast with (20µg) 25(OH) D3 fortified milk and butter

Dietary Supplement: 25(OH) D3

Control

PLACEBO COMPARATOR

subjects are asked to consume a normal milk and butter (no vitamin D is added) in the breakfast

Dietary Supplement: Control

Interventions

vitamin D3 DIETARY_SUPPLEMENT

Subjects are asked to consume a breakfast rich in 20 µg vitamin D3

Also known as: cholecalciferol

breakfast rich in vitamin D3

25(OH) D3 DIETARY_SUPPLEMENT

Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3

Also known as: calcifediol

breakfast rich in 25(OH) D3

Control DIETARY_SUPPLEMENT

Subjects are asked to consume a breakfast without vitamin D

Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI: 20-35 kg/m2
• Glucose \<7 mmol/l (not diagnosed with diabetes)
• Total cholesterol \<7 mmol/l
• TAG \<4 mmol/l
• Serum 25(OH)D3 ≤50 nmol/L
• Normal liver and kidney function
• Haemoglobin: adult male \>125 g/L

You may not qualify if:

• Milk allergy/intolerance or lactose intolerance
• Cardiovascular, renal, gastrointestinal, respiratory, endocrine disease or cancer
• Use of nutritional supplements, particularly those containing vitamin D
• Outdoor workers and use of tanning beds
• Overseas holidays two months before or during study period

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (1)

• Guo J, Jackson KG, Che Taha CSB, Li Y, Givens DI, Lovegrove JA. A 25-Hydroxycholecalciferol-Fortified Dairy Drink Is More Effective at Raising a Marker of Postprandial Vitamin D Status than Cholecalciferol in Men with Suboptimal Vitamin D Status. J Nutr. 2017 Nov;147(11):2076-2082. doi: 10.3945/jn.117.254789. Epub 2017 Sep 20.

  PMID: 28931588 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Cardiovascular Diseases

Interventions

Cholecalciferol; Calcifediol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Hydroxycholecalciferols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Julie Lovegrove

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 31, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

GB (1)