Effect of Polyphenols on Iron Absorption From Finger Millet

NCT04194567 | Completed DMC

• 1 other identifier: Ragi
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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 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

Conditions

Iron-deficiency

Keywords

polyphenols; iron deficiency; finger millet; iron bioavailability

Outcome Measures

Primary Outcomes (2)

• 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

  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

  26th day of the study

Secondary Outcomes (5)

• Hemoglobin

  screening (-1), baseline (day 1), last test meal consumption (day 26)

• Plasma ferritin

  screening (-1), baseline (day 1), last test meal consumption (day 26)

• C-Reactive Protein

  screening (-1), baseline (day 1), last test meal consumption (day 26)

• Body Iron stores

  last test meal consumption (day 26)

• Soluble transferrin receptor

  last test meal consumption (day 26)

Study Arms (2)

Black Ragi

EXPERIMENTAL

During one week of the study, participants are to consume pancakes made from the dark variety of ragi.

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

Other: White Ragi

Interventions

Black Ragi OTHER

Pancakes made out of the dark ragi

Black Ragi

White Ragi OTHER

Pancakes made out of the white ragi

White Ragi

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only female participants enrolled in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• St. John's Research Institute: collaborator

Study Sites (2)

ETH Zürich, Laboratory of Human Nutrition

Zurich, Canton of Zurich, 8092, Switzerland

Location

ETH Zurich, Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 11, 2019
• Study Start: November 4, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

CH (2)