Evaluating Iron and Zinc Bioavailability From Biofortified Potatoes to Reduce Malnutrition in the Andean Highlands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 4
- 主要终点
- Percent of iron absorption from a biofortified potato vs non-biofortified potato
研究概览
简要总结
Two of the most common nutritional deficiencies are anemia and zinc deficiency. One strategy for combating nutritional deficiencies is biofortification. The primary objective of the proposed research is to determine in humans the bioavailability of iron and zinc from biofortified potatoes as compared to a non-fortified local variety. The secondary objective is to use the data obtained from the human studies to model the potential impact of the introduction of biofortified potatoes to the alleviation of iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere.
Iron bioavailability studies: The investigators will compare bioavailability of iron from a non-fortified potato variety with a biofortified potato that has significantly higher iron content though the use of a randomized cross-over intervention study. Female volunteers will consume both biofortified potato extrinsically labelled with 58FeSO4 and a nonfortified potato labelled with 57FeSO4. Thirty women with marginal iron status (plasma ferritin < 25 ng/ml) will be selected from an initial screening of 180 women. Every woman will receive 2 different types of test meals in a series of 20 servings for 10 days each. Blood samples will be collected during screening and on days 1, 15, 26 and 40 and the amount of 58Fe and 57Fe incorporated into hemoglobin and serum ferritin quantified.
Zinc bioavailability study: The investigators will compare bioavailability of zinc from a non-fortified potato variety with that of a biofortified potato that has significantly higher zinc content (p<0.001) with a crossover study. Forty volunteers will be randomly assigned to receive first either the biofortified or the non-fortified potato and receive the second meal 30 days later. Zinc absorption from two meals will be measured using the double stable isotope technique. Every volunteer will be given an i.v. infusion of 70zinc and two test meals of 250 g cooked potato labelled extrinsically with 67zinc separated by 3-4 hr. A spot urine sample will be collected 96 hours after each set of test meal and the ratio of the two isotopes measured to calculate absorption of zinc from the test meal.
Modelling and Impact assessment: Data on bioavailability will be used in a Disability Adjusted Life Year model to assess the potential impact of biofortified potatoes to alleviate iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere.
详细描述
Type of Study and population Double blind randomized trial of naturally biofortified potatoes to be carried out in Huancavelica, Perú. It will be recruited about 100 women and 80 men aged 18-45 years living in the city of Huancavelica.
ETHICS Applications was submitted and approved by Research Ethics Committee (REC) of the University of East Anglia Faculty of Medicine and Health (FMH) in Norwich (UK) and a REC of the Instituto de Investigacion Nutricional (IIN) in Peru.
Every participant will be fully informed of all the procedures and will be given the opportunity to ask questions and receive any further details participants require.
The procedures (blood samples, urine samples, anthropometry, dietary recall) will be explained to the individuals who agree to take part in the initial screening, and participants will be invited to sign the first consent form.
SPECIFIC METHODS FOR IRON STUDY (Phase 1) Sample size The study requires an enrollment of a total of 30 women to allow for 33% who do not adhere to the protocol, to reach a final sample size of 20 women. The investigators estimate that the investigators may need to screen about 100 women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •FOR IRON PART:
- •Inclusión Criteria:
- •Healthy women aged 18-45 years
- •Marginal levels of iron in blood as measured by serum ferritin <25ug/L.
- •BMI: 18.5 to 25 kg/m
- •Body weight <65kg.
- •Prepared to attend study visits at the investigator site over a period of approximately 4 weeks (total 20 days) and, eat each day the prepared potatoes and then stay for a further 3 hours after eating the potato.
- •Able to understand study requirements and provide written informed consent.
排除标准
- •Severe anaemia (Hb<80g/L)
- •Evidence of inflammation as measured by C-reactive protein (CRP) (>5mg/100ml).
- •Gastrointestinal or renal problems; self-reported metabolic disease based on prior diagnosis, or a prior screening questionnaire.
- •Pregnancy (positive urine test).
- •Currently breastfeeding.
- •Currently taking any medication, antibiotic or supplement that might be expected to affect iron metabolism.
- •Not willing to discontinue taking iron supplements for at least 2 weeks before taking part in the study.
- •No significant blood loss in the last 6 months due to trauma, major surgery or blood donation.
- •Not able to eat the full amount of the potato.
- •Allergy to any ingredients of the test meal.
- •INCLUSION CRITERIA FOR ZINC PART:
- •Inclusion Criteria:
- •Healthy women aged 18-45 years.
- •BMI 18.5-25 kg/m
- •Willing to come to the study centre to eat the prepared potatoes on two occasions with a wash-out of 30 days (each day a different variety of potato) and to remain in the study centre for 7-8 hours in both occasions (one day to eat the biofortified variety and the other day the common variety) and as well to comply with all the study processes.
- •Able to understand the consent form and to sign it.
- •Exclusion criteria
- •Severe anaemia (Hb<80g/dL adjusted for altitude).
- •Inflammation measured as CRP (>5mg/100ml).
- •Gastrointestinal, renal problems, metabolic illness (self-reported or prior diagnosis or evident from replies in a questionnaire).
- •Pregnant (urine test).
- •Breastfeeding.
- •Taking medication, antibiotic or supplement that could affect zinc metabolism.
- •Not willing to discontinue supplements for at least 2 weeks before participating in the study.
- •Significant blood loss in the last 6 months due to trauma, surgery or blood donation.
- •Unable to eat all the potato.
- •Allergy to any ingredients of the test meal.
结局指标
主要结局
Percent of iron absorption from a biofortified potato vs non-biofortified potato
时间窗: 40 days
Percent of of iron absorption from a biofortified potato is higher as compared to a non-fortified local variety.
次要结局
- Percent of zinc absorption from a biofortified potato vs non-biofortified potato(35 days)