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临床试验/NCT06327529
NCT06327529招募中不适用

Zinc and Iron Absorption From Common Beans in Young Adult Women

University of California, Davis1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Fractional Zinc absorption

研究概览

简要总结

Fifteen female study participants will be enrolled in a randomized crossover study to measure fractional and total zinc and iron absorption from four common bean (Phaseolus vulgaris) varieties with varying phytate and polyphenolic contents. Phytate, the storage form of phosphorus in plants, and polyphenols, which contribute to the varied colors of common beans, are natural components of the beans and can reduce zinc and iron bioavailability from these foods.

详细描述

Each participant will attend a total of 10 study visits. The first visit will be a screening visit to determine eligibility, and will include the administration of health history and food frequency questionnaires, and a urine pregnancy test. Participant will also be given a ASA24 24-hour dietary recall at visit 1 to return at visit 2. All subsequent visits (2 through 10) will begin with a blood sample (15 mL, or 1 tablespoon, after a 12 hour overnight fast).

Visit 2 will establish the baseline distribution of naturally occurring zinc and iron isotopes in the blood, and will include the administration of water enriched in zinc of a specific naturally-occurring isotopic mass (zinc-68, 4 mg).

Visits 2-5 will be on consecutive days, while Visit 6 will be 14 days following Visit 5. Visits 3 and 4 will include breakfast, lunch, and dinner, each containing a small serving of beans that are enriched in specific isotopic masses of iron and zinc (2 mg each of zinc-67 and iron-57, or 1 mg each of zinc-70 and iron-58). Visits 5 and 6 are for blood sampling, to measure the zinc in blood plasma (Visit 5) and the iron that has reached a 14-day equilibrium in red blood cells (Visit 6). Participants will also be given a ASA24 24-hour dietary recall at visit 6 to return at visit 7.

Visits 6-9 will be on consecutive days, starting 28 days (the approximate length of one menstrual cycle) after Visit 3, while Visit 10 will be 14 days following Visit 9. The 28-day timing is needed to minimize the potential influence of natural variation in circulating hormones, on zinc metabolism. A second urine pregnancy test will be administered on Visit 10, to detect any pregnancies that would have occurred at the time of the study meals 2 weeks prior or earlier. Participants will also be given a ASA24 dietary recall at visit 9 to return at visit 10.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Study participants will be masked to the type of bean that they will be receiving.

入排标准

年龄范围
19 Years 至 24 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy eumenorrheic (regular monthly menstrual cycles of 25-30-days in length)
  • BMI 18.5 - 30 kg/m2
  • Regular consumer of beans, i.e. ≥ 4 servings per month
  • Usual iron intake estimated by Food Frequency Questionnaire to be less than the Recommended Daily Allowance (RDA) of 18 mg/d (8)
  • Subject is willing and able to comply with the study protocols.
  • Subject is willing to participate in all study procedures.

排除标准

  • Dislike or allergy to beans
  • Self-reported current or recent pregnancy (within the past 12 months)
  • Self-reported recent termination of pregnancy (3 months if abortion in 1st or 2nd trimester, or 12 months if in 3rd trimester)
  • Self-reported plans to become pregnant during the study period
  • Self-reported cancer
  • Self-reported surgery without the past 12 months
  • Currently taking prescription drugs, other than for contraception, or any nutritional supplements
  • Any daily iron supplementation within the past 12 months.
  • Currently breastfeeding
  • Any medical conditions affecting iron or zinc metabolism (such as hemochromatosis or sickle cell disease)

研究组 & 干预措施

Bean Variety 2

Experimental

Enriched with Zinc-70, Iron-58

干预措施: LMP 1001 (Other)

Bean Variety 3

Experimental

Enriched with Zinc-67, Iron-57

干预措施: LPA 586 (Other)

Bean Variety 4

Experimental

Enriched with Zinc-70, Iron-58

干预措施: KAT B1 (Other)

Bean Variety 1

Experimental

Enriched with Zinc-67, Iron-57

干预措施: SER 118 (Other)

结局指标

主要结局

Fractional Zinc absorption

时间窗: 24 hours after first intake

amount of zinc absorbed and circulating in blood

Fractional Iron absorption

时间窗: 24 hours after first intake

amount of iron absorbed and circulating in the blood

次要结局

  • Total Zinc absorption(24 hours after first intake)
  • Total Iron absorption(24 hours after first intake)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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