NCT05840848

Brief Summary

In vitro studies found supplemental levels of iron and zinc to inhibit the micellization and cellular uptake of β-carotene. Here, we investigated this in vivo, in a double-blind 3-arm crossover human trial. Healthy males (n=6) ingested, with breakfast, a single dose of 15 mg β-carotene in combination with either a placebo, 25 mg iron or 30 mg zinc capsule. Blood samples were collected at baseline and hourly for 10 hours. The triacylglycerol-rich fraction (TRF) was analysed for concentrations of β-carotene and plasma for β-carotene, retinol, triacylglycerols, LDL- and HDL-cholesterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 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 21, 2017

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

23 days

First QC Date

March 28, 2023

Last Update Submit

May 2, 2023

Conditions

Bioavailability

Keywords

B-caroteneIronzincSupplements

Outcome Measures

Primary Outcomes (2)

  • TRF B-carotene

    B-carotene concentration in the triacylglycerol-rich fraction of the plasma

    10 hours

  • Plasma B-carotene

    B-carotene concentration int he plasma

    10 hours

Secondary Outcomes (5)

  • Plasma LDL-cholesterol

    10 hours

  • Plasma HDL-cholesterol

    10 hours

  • Plasma TAG

    10 hours

  • liver function markers

    4 hours

  • Kidney funtion markers

    4 hours

Study Arms (3)

Control plus Placebo

ACTIVE COMPARATOR

B-carotene supplement (15 mg) consumed in the morning after a \>10 hour overnight fast.

Dietary Supplement: Control beta-carotene supplement plus Placebo

Control plus iron Supplement

EXPERIMENTAL

B-carotene supplement (15 mg) and iron sulphate supplement (25 mg) consumed in the morning after a \>10 hour overnight fast.

Dietary Supplement: Control beta-carotene supplement plus iron Supplement

Control plus zinc Supplement

EXPERIMENTAL

B-carotene supplement (15 mg) and zinc sulphate supplement (30 mg) consumed in the morning after a \>10 hour overnight fast.

Dietary Supplement: Control beta-carotene supplement plus zinc Supplement

Interventions

Control beta-carotene supplement plus PlaceboDIETARY_SUPPLEMENT

15 mg beta-carotene supplement from BIOVEA consumed before breakfast together with an empty capsule.

Control plus Placebo
Control beta-carotene supplement plus iron SupplementDIETARY_SUPPLEMENT

15 mg Beta-carotene supplement from BIOVEA consumed before breakfast together with 25 mg iron (FeSO4; Woerwag Pharma GmbH \& Co. KG, Boeblingen, Germany)

Control plus iron Supplement
Control beta-carotene supplement plus zinc SupplementDIETARY_SUPPLEMENT

15 mg Beta-carotene supplement from BIOVEA consumed before breakfast together with 30 mg zinc (ZnSO4; Woerwag Pharma GmbH \& Co. KG, Boeblingen, Germany)

Control plus zinc Supplement

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWomen were excluded from the study because the concentrations and distribution of carotenoids in the lipoprotein fractions fluctuate throughout the menstrual cycle
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • aged 18 and 50 years

You may not qualify if:

  • overweight (BMI \>25 kg/m2),
  • metabolic and endocrine diseases,
  • drug abuse,
  • use of dietary supplements,
  • us of any form of medication,
  • smoking,
  • frequent alcohol consumption (\>20 g ethanol/day),
  • adherence to a restrictive dietary regimen,
  • physical activity of more than 5 h/wk,
  • participation in a clinical trial within the past 3 months prior to recruitment,
  • a known intolerance against β-carotene, iron and/or zinc supplements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

Related Publications (1)

  • Kruger J, Sus N, Moser A, Scholz S, Adler G, Venturelli S, Frank J. Low beta-carotene bioaccessibility and bioavailability from high fat, dairy-based meal. Eur J Nutr. 2024 Sep;63(6):2261-2270. doi: 10.1007/s00394-024-03423-w. Epub 2024 May 16.

    PMID: 38753174DERIVED

MeSH Terms

Interventions

Iron-Dextran Complex

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: double-blind crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. (PhD)

Study Record Dates

First Submitted

March 28, 2023

First Posted

May 3, 2023

Study Start

November 21, 2017

Primary Completion

December 14, 2017

Study Completion

June 1, 2018

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

DE(1)