Iron-deficiencyNCT04194567
Effect of Polyphenols on Iron Absorption From Finger Millet
A study testing Black Ragi and White Ragi in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 2 sites in Switzerland.
Trial summary
In India, one of the fast growing countries, 53% of all women have anaemia as per the National Family Health Survey. A recently published study on the burden of disease in India concluded that the burden of Iron deficiency anaemia (IDA) is 3 times higher than the average globally for other geographies at a similar… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Black Ragi and White Ragi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 4 Nov 2019to 29 Nov 2019
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18 to 40 years old
- Body weight up to 65 kg
- Normal Body Mass Index (18.5 - 25 kg/m2)
- Signed informed consent
- Plasma ferritin < 25 ng/ml
- Able to communicate in and comprehend English language
- Tasted and found the Ragi to be of acceptable taste and confirmed will to consume the test meals if enrolled in the study
Who cannot join
- Pregnancy (assessed by a urinary pregnancy test) / intention to become pregnant
- Lactating up to 6 weeks before study initiation
- Moderate or severe anaemia (Hb < 9.0 g/dL)
- Elevated CRP (> 5.0 mg/L)
- Any metabolic, gastrointestinal, kidney or chronic disease such as celiac disease, diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives)
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- Consumption of mineral and vitamin supplements within 2 weeks prior to first meal administration
- Blood transfusion, blood donation or significant blood loss (accident, surgery) within 4 months prior to first meal administration
- Earlier participation in a study using iron stable isotopes or participation in any clinical study within the last 30 days
- Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood withdrawal)
- Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
ETH Zürich, Laboratory of Human Nutrition
Zurich, Canton of Zurich, 8092
ETH Zurich, Laboratory of Human Nutrition
Zurich, 8092
About this study
Official title: An Absorption Study in Young Women to Evaluate the Effect of Polyphenols on Iron Absorption From Ragi (Finger Millet) Using the Iron Isotopic Method
In India, one of the fast growing countries, 53% of all women have anaemia as per the National Family Health Survey. A recently published study on the burden of disease in India concluded that the burden of Iron deficiency anaemia (IDA) is 3 times higher than the average globally for other geographies at a similar level of development, and that women are disproportionately affected. Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat. Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47%. The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers
Read the detailed description
Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, including other countries especially in East Africa. Ragi has been perceived as a potential "super cereal" by the United States National Academies being one of the most nutritious among all major cereals. From the nutritional perspective, finger millet is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat .
Millets (Ragi or finger millet and Jowar or sorghum) were consumed by 59% of rural and 28% of urban population in Karnataka. Ragi consumption was seen predominantly in south Karnataka with 27% of rural and 17% of urban population reporting consumption.
Ragi is the richest source of calcium among cereals with up to 10-fold higher calcium content than brown rice, wheat or maize and three times than that of milk. It is also rich in iron and fiber, making this crop more nutritive as compared to other most commonly used cereals. Finger millet is enriched in the essential amino acids like lysine and methionine which are important in human health and growth but remain absent from most other plant foods . In addition, it also contains useful amounts of the two polyunsaturated fatty acids- linoleic acid and α-linolenic acid , metabolized products of which facilitate normal development of the central nervous system. Despite the well-documented health benefits of finger millet, only a limited progress has been made in context to its nutraceutical applications as functional food. Although, it may have remained underutilized by the general population due to either unawareness or apprehension, its immense potential for enhancing the nutritional and therapeutic attributes by acting as functional food cannot be ignored.
Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47% . It was found that found proto-catechuic acid (45.0 mg/100 g) is the major free phenolic acid in ragi. In another study of total phenolic compounds in finger millet, it was found to have 85% benzoic acid derivatives (gallic acid, protocatechuic acid, p-hydroxybenzoic acid, vanillic acid, syringic acid) while rest of the fraction were either cinnamic acid derivatives (ferulic acid, trans-cinnamic acid, p-coumaric acid, caffeic acid, sinapic acid) or flavonoids (quercetin, Proanthocyanidins like condensed tannins) . Among bound phenloic acids, ferulic and p-coumaric acid are the major fractions and account for 64-96 and 50-99% of total ferulic and p-coumaric acid content of finger millet grains, respectively.
The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers
The study duration will be 26 days from the first day of the first meal administration till the last blood withdrawal . For each appointment, the participants will spend about 30 minutes at the Human Nutrition Laboratory at ETH Zurich, between 7 and 9 am for breakfast meal consisting of pancakes made out of the ragi. the white ragi meal and the black ragi meal will be extrinsically labelled with isotopes 57 Fe and 58 Fe respectively. The participants will consume the ragi meal as breakfast. The first type of ragi meal will be given for 5 consecutive days,. They will have a weekend break of two days (during which they will resume their usual eating habits). After that, they will consume the second test meal as breakfast for another five consecutive days. Thus, there will be 10 meals in total. The breakfast meals will be consumed between 7 and 9 am together with a glass of 300 mL bottled water after which they have to wait another 3 hours before they can consume anything. The procedure will remain the same for all the days. Participants will always be asked to fast the day before coming for the feeding, that is, no food intake after 8 pm and no beverage intake after midnight the evening before. On day of screening, day 1 and the end point day 26 of the study, blood samples will be collected after an overnight fast for the determination of Hb, PF, CRP and isotopic ratio
- Conditions
- Iron-deficiency
- Being tested
- Black Ragi, White Ragi
- Keywords
- polyphenols, iron deficiency, finger millet, iron bioavailability
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black RagiOther
Pancakes made out of the dark ragi
White RagiOther
Pancakes made out of the white ragi
| Study group | Role | What they receive |
|---|---|---|
| Black Ragi | Experimental | During one week of the study, participants are to consume pancakes made from the dark variety of ragi. Receives: Other: Black Ragi |
| White Ragi | Experimental | During the second week of the study, participants are to consume pancakes made from the white variety of ragi Receives: Other: White Ragi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Iron absorption
The fractional iron absrption will be compared in predefined comparisons from the two interventions products that are administered to the study participants
Measured: 26th day of the study
Total Iron Absorption
Total iron absorption from the two ragi types will be compared by measuring the total iron absorbed from all the meals in the study
Measured: 26th day of the study
Secondary outcomes (5)
Hemoglobin
Iron status marker
Measured: screening (-1), baseline (day 1), last test meal consumption (day 26)
Plasma ferritin
Iron status marker
Measured: screening (-1), baseline (day 1), last test meal consumption (day 26)
C-Reactive Protein
Inflammation status
Measured: screening (-1), baseline (day 1), last test meal consumption (day 26)
Body Iron stores
Iron status marker
Measured: last test meal consumption (day 26)
Soluble transferrin receptor
Iron status marker
Measured: last test meal consumption (day 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start4 Nov 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will have a randomized, cross-over design and will be conducted at the Human Nutrition Laboratory, ETH Zurich (scientific responsibility). From an initial screening of 150 women, 25 non-pregnant non-lactating women with a marginal iron status (PF \<25 ng/ml) will be recruited. In total, participants will consume the 2 intervention products in a random, balanced order. Participants will consume the first intervention product as a breakfast meal for 5 days in a week, and the second intervention product as a breakfast meal as well for 5 days the following week. A blood sample will be collected 14 days after the last meal administration day which will be used to measure the shift in the isotopic ratio
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. John's Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194567
- Sponsor's protocol ID
- Ragi
- Status last verified
- Dec 2019
- First submitted
- 21 Nov 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Absorption Study in Young Women to Evaluate the Effect of Polyphenols on Iron Absorption From Ragi (Finger Millet) Using the Iron Isotopic Method
- ClinicalTrials.gov ID
- NCT04194567
- Acronym / sponsor ID
- Ragi
- Conditions
- Iron-deficiency
- Keywords
- polyphenols, iron deficiency, finger millet, iron bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- St. John's Research Institute
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 11 Dec 2019 (actual)
- 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.
In India, one of the fast growing countries, 53% of all women have anaemia as per the National Family Health Survey. A recently published study on the burden of disease in India concluded that the burden of Iron deficiency anaemia (IDA) is 3 times higher than the average globally for other geographies at a similar level of development, and that women are disproportionately affected. Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat. Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47%. The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers
Detailed description
Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, including other countries especially in East Africa. Ragi has been perceived as a potential "super cereal" by the United States National Academies being one of the most nutritious among all major cereals. From the nutritional perspective, finger millet is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat .
Millets (Ragi or finger millet and Jowar or sorghum) were consumed by 59% of rural and 28% of urban population in Karnataka. Ragi consumption was seen predominantly in south Karnataka with 27% of rural and 17% of urban population reporting consumption.
Ragi is the richest source of calcium among cereals with up to 10-fold higher calcium content than brown rice, wheat or maize and three times than that of milk. It is also rich in iron and fiber, making this crop more nutritive as compared to other most commonly used cereals. Finger millet is enriched in the essential amino acids like lysine and methionine which are important in human health and growth but remain absent from most other plant foods . In addition, it also contains useful amounts of the two polyunsaturated fatty acids- linoleic acid and α-linolenic acid , metabolized products of which facilitate normal development of the central nervous system. Despite the well-documented health benefits of finger millet, only a limited progress has been made in context to its nutraceutical applications as functional food. Although, it may have remained underutilized by the general population due to either unawareness or apprehension, its immense potential for enhancing the nutritional and therapeutic attributes by acting as functional food cannot be ignored.
Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47% . It was found that found proto-catechuic acid (45.0 mg/100 g) is the major free phenolic acid in ragi. In another study of total phenolic compounds in finger millet, it was found to have 85% benzoic acid derivatives (gallic acid, protocatechuic acid, p-hydroxybenzoic acid, vanillic acid, syringic acid) while rest of the fraction were either cinnamic acid derivatives (ferulic acid, trans-cinnamic acid, p-coumaric acid, caffeic acid, sinapic acid) or flavonoids (quercetin, Proanthocyanidins like condensed tannins) . Among bound phenloic acids, ferulic and p-coumaric acid are the major fractions and account for 64-96 and 50-99% of total ferulic and p-coumaric acid content of finger millet grains, respectively.
The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers
The study duration will be 26 days from the first day of the first meal administration till the last blood withdrawal . For each appointment, the participants will spend about 30 minutes at the Human Nutrition Laboratory at ETH Zurich, between 7 and 9 am for breakfast meal consisting of pancakes made out of the ragi. the white ragi meal and the black ragi meal will be extrinsically labelled with isotopes 57 Fe and 58 Fe respectively. The participants will consume the ragi meal as breakfast. The first type of ragi meal will be given for 5 consecutive days,. They will have a weekend break of two days (during which they will resume their usual eating habits). After that, they will consume the second test meal as breakfast for another five consecutive days. Thus, there will be 10 meals in total. The breakfast meals will be consumed between 7 and 9 am together with a glass of 300 mL bottled water after which they have to wait another 3 hours before they can consume anything. The procedure will remain the same for all the days. Participants will always be asked to fast the day before coming for the feeding, that is, no food intake after 8 pm and no beverage intake after midnight the evening before. On day of screening, day 1 and the end point day 26 of the study, blood samples will be collected after an overnight fast for the determination of Hb, PF, CRP and isotopic ratio
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will have a randomized, cross-over design and will be conducted at the Human Nutrition Laboratory, ETH Zurich (scientific responsibility). From an initial screening of 150 women, 25 non-pregnant non-lactating women with a marginal iron status (PF <25 ng/ml) will be recruited. In total, participants will consume the 2 intervention products in a random, balanced order. Participants will consume the first intervention product as a breakfast meal for 5 days in a week, and the second intervention product as a breakfast meal as well for 5 days the following week. A blood sample will be collected 14 days after the last meal administration day which will be used to measure the shift in the isotopic ratio
| Arm | Type | Receives |
|---|---|---|
| Black Ragi | Experimental | Other: Black RagiDuring one week of the study, participants are to consume pancakes made from the dark variety of ragi. |
| White Ragi | Experimental | Other: White RagiDuring the second week of the study, participants are to consume pancakes made from the white variety of ragi |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female, 18 to 40 years old
- Body weight up to 65 kg
- Normal Body Mass Index (18.5 - 25 kg/m2)
- Signed informed consent
- Plasma ferritin < 25 ng/ml
Key exclusion criteria (11 listed)
- Pregnancy (assessed by a urinary pregnancy test) / intention to become pregnant
- Lactating up to 6 weeks before study initiation
- Moderate or severe anaemia (Hb < 9.0 g/dL)
- Elevated CRP (> 5.0 mg/L)
- Any metabolic, gastrointestinal, kidney or chronic disease such as celiac disease, diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
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 |
|---|---|---|
| Black RagiPancakes made out of the dark ragi | Other | Black Ragi |
| White RagiPancakes made out of the white ragi | Other | White Ragi |
Primary outcome
Fractional Iron absorption
Time frame: 26th day of the study
The fractional iron absrption will be compared in predefined comparisons from the two interventions products that are administered to the study participants
Total Iron Absorption
Time frame: 26th day of the study
Total iron absorption from the two ragi types will be compared by measuring the total iron absorbed from all the meals in the study
5 secondary outcomes
Hemoglobin
Time frame: screening (-1), baseline (day 1), last test meal consumption (day 26)
Plasma ferritin
Time frame: screening (-1), baseline (day 1), last test meal consumption (day 26)
C-Reactive Protein
Time frame: screening (-1), baseline (day 1), last test meal consumption (day 26)
Body Iron stores
Time frame: last test meal consumption (day 26)
Soluble transferrin receptor
Time frame: last test meal consumption (day 26)
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 11 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Ragi and White Ragi in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 2 sites in Switzerland.
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 7 inclusion and 11 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Fractional Iron absorption (time frame: 26th day of the study). The study lists 2 primary outcomes in all. 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 11 Dec 2019.