- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05220735
Omega-3 Fatty Acid Supplementation and Fractional Iron Absorption in Obese South African Women
Effects of Omega-3 Fatty Acid Supplementation on Fractional Iron Absorption in South African Women Living With Obesity: A Stable Iron Isotope Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Iron deficiency (ID) and iron-deficiency anaemia (IDA) remain a major public health problem in low- and middle-income countries (LMICs). Women of reproductive age are at high risk of developing ID due to loss of iron through menstruation. Furthermore, inadequate iron status at conception and during pregnancy can have detrimental effects on the developing offspring. In addition to ID, the prevalence of obesity is increasing globally, including in LMICs. South Africa is a country with a high prevalence of obesity, especially in women of reproductive age (36 %), and a persistent burden of ID despite a mandatory maize meal and wheat flour fortification programme. Obesity is a condition associated with low-grade systemic inflammation. Inflammation increases the expression of hepcidin, leading to a reduction in duodenal iron absorption. Previous studies have shown that iron absorption differs between normal weight and obese individuals, and that the enhancing effect of ascorbic acid on iron absorption is lower in obese subjects. A possible explanation is the different sites of action of ascorbic acid and hepcidin on the enterocytes: Ascorbic acid enhances iron transport into enterocytes at the luminal side (via divalent metal transporter-1), while hepcidin reduces iron absorption by ferroportin inhibition at the basolateral membrane of the enterocyte. Thus, in obese individuals, an intervention at the basolateral membrane of the enterocyte will be needed. Supplementation with n-3 long-chain polyunsaturated fatty acids (LCPUFA) has been shown to exert cardiometabolic benefits, and to reduce inflammation in obese individuals.
The aim of this study is to investigate the effect of n-3 LCPUFA supplementation on fractional iron absorption in obese South African women of reproductive age. As a secondary objective, this study will determine association between omega-3 fatty acid status, inflammation and iron status in obese South African women. The hypothesises are: 1) fractional iron absorption will increase following n-3 LCPUFA supplementation; 2) iron absorption will further increase in the presence of ascorbic acid following n-3 LCPUFA supplementation.
After screening, apparently healthy, non-anaemic, obese South African women of African descent, aged 18 to 35 years, with low-grade inflammation and a low n-3 LCPUFA status, will receive daily oral fish oil (2.1 g of n-3 LCPUFA) capsules for three months. Iron status indices, inflammatory markers, hepcidin and omega-3 fatty acid index will be assessed at screening. The same variables will be emasured again at baseline and endpoint, in addition to erythrocyte total phospholipid fatty acid composition. Iron absorption will be determined from test meals with and without ascorbic acid using the oral stable isotope method, before (baseline) and after (endpoint) supplementation with n-3 LCPUFA.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Prof. Marius Smuts, PhD
- Phone Number: +27 18 299 2086
- Email: Marius.Smuts@nwu.ac.za
Study Locations
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-
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Potchefstroom, South Africa
- Centre of Excellence for Nutrition, North-West University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-classified women from African descent and of reproductive age (18 - 35 years)
- BMI ≥ 28kg/m2 (indicating obesity)
- Midly- or non-anaemic (Hb ≥11 g/dl)
- Low n-3 LCPUFA status (RBC omega-3 index < 6%)
- Low grade systemic inflammation (HS-CRP ≥ 2 mg/l but ≤ 20 mg/l)
- Be able to read and understand English
Exclusion Criteria:
- Treated chronic disease or gastrointestinal disorders
- Regular use of medication (except oral contraceptives, others after approval by the investigator) and women receiving treatment for high blood pressure
- Current consumption of iron or n-3 LCPUFA or ascorbic acid-containing supplements other than the supplements provided (Participants will be asked to discontinue use three weeks prior to enrolment)
- Subject on a weight loss diet or planning to start a weight loss diet during the duration of the study
- Pregnancy or lactation
- Subjects who cannot be expected to comply with the study protocol
- Subjects who are smoking
- Difficulty drawing blood due to poor quality veins
- Individuals that have a fear of needles or suffer from vaso-vagal episodes when exposed to blood
- Subjects with fish allergies
- Participants who plan to start or stop the use of contraceptives in the following 4 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Participants will receive three fish oil capsules daily for 14 weeks, and fractional iron absorption from test meals provided without and with ascorbic acid will be determined at baseline and endpoint.
|
3 three fish oil capsules providing 2.1 g n-3 PUFA; 1.27 g Docosahexanoic acid (DHA) and 0.86 g Eicosapentanoic acid (EPA) capsules. The absorption study test meals will consist of white bread with butter and honey, 6mg of labeled iron as ferrous sulfate and 300 g of distilled water. The meal will be given on two days without and with ascorbic acid. The test meals without ascorbic acid will contain 6 mg 57Fe as ferrous sulfate whereas the meals containing ascorbic acid will contain 6 mg 58Fe as ferrous sulfate. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fractional iron absorption (%)
Time Frame: Change between baseline and 3 months (days 17 and 118)
|
Fractional iron absorption will be assessed from labeled meals consumed without and with ascorbic acid, before and after intervention with n-3 LCPUFA.
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Change between baseline and 3 months (days 17 and 118)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Haemoglobin (g/dL)
Time Frame: Screening, days 1 and 102
|
Haemoglobin will be measured in whole blood to determine presence of anaemia.
|
Screening, days 1 and 102
|
Ferritin (µg/L )
Time Frame: Screening, days 1 and 102
|
Ferritin will be measured in plasma to determine the presence of iron deficiency.
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Screening, days 1 and 102
|
Soluble transferrin receptor (mg/L)
Time Frame: Screening, days 1 and 102
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Soluble transferrin receptor will be measured in plasma to determine the presence of iron deficiency.
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Screening, days 1 and 102
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Hepcidin concentration
Time Frame: Screening, days 1 and 102
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Hepcidin, a major regulator of iron absorption and influenced by inflammation, will be measured in plasma.
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Screening, days 1 and 102
|
C-reactive protein (mg/L)
Time Frame: Screening, days 1 and 102
|
C-reactive protein will be measured in plasma to determine the presence of acute inflammation.
|
Screening, days 1 and 102
|
Alpha-1-acid glycoprotein (g/L)
Time Frame: Screening, days 1 and 102
|
Alpha-1-acid glycoprotein will be measured in plasma to determine the presence of chronic inflammation.
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Screening, days 1 and 102
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Intestinal fatty acid-binding protein
Time Frame: Screening
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Intesinal fatty acid-binding protein will be measured in plasma as a marker of intestinal damage.
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Screening
|
Omega-3 fatty acid index (%)
Time Frame: Screening
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Omega-3 fatty acid index, a measure of eicosapentanoic and docosahexanic acids will be measued in red blood cells.
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Screening
|
Cytokines (pg/ml)
Time Frame: Screening, days 1 and 102
|
Cytokines: Interleukin (IL) IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, Interferon gamma and Tumor necrosis factor-beta will be measured in plasma as markers of inflammation.
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Screening, days 1 and 102
|
Erythrocyte fatty acid composition
Time Frame: Days 1 and 102
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Fatty acid composition and status will be determined in erythrocyte phospholipids.
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Days 1 and 102
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Lipid mediators (mol/mL or pmol/mL)
Time Frame: Days 1 and 102
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The following lipid mediators will be measured in plasma: 17-Hydroxydocosahexanoic acid, 5-, 8-, 11-, 12-, 15- and 18-Hydroxyeicosapentanoic acid (HEPE); 5-, 8-, 11-, 12- and 15-Hydroxyeicosatetraenoic acids (HETE); Prostaglandinds E2, E3 and D2; Protectin D1 and Resolvin D1 and E1.
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Days 1 and 102
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Genetic variants in genes associated with fatty acid metabolism
Time Frame: Days 1 and 102
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Single nucleotide polymorphism (SNP) analyses of genes involved in fatty acid metabolism will be measured from stored buffy coat.
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Days 1 and 102
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FeMEGA-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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