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临床试验/NCT04572607
NCT04572607已完成不适用

Effect of Avocado Honey (Apis Mellifera) on Anthropometric and Biochemical Parameters in Healthy Subjects: A Pilot Study

Universidad Autonoma de Nuevo Leon2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Subject numbers that experienced change of LDL-cholesterol levels (mg/dL) post-intake of 25 g/day honey

研究概览

简要总结

Thirteen healthy subjects (5 males; 8 females) ages 25-50 years, with BMI (body mass index): <25 kg/m2 completed the study. The participants were selected randomly, either the control group (n= 7) or honey group (n= 6). Subjects of honey group consumed 25 g of honey each day for 4 weeks.

详细描述

18 healthy participants (body mass index [BMI] <25 kg/m2) between 25-50 years of age were recruited, of which 13 subjects (male [n=5]) and female [n=8]) completed the study. The participants were allocated randomly either control group (n= 7) or honey group (n= 6). Subjects of honey group consumed 25 g of honey each day for 4 weeks. Participants of both groups did not undergo a special diet regimen, drug therapy, or change in their lifestyle, such as physical exercise, during the period of study. A 3- day food record including two weekdays and one weekend day was used to assess the habitual food intake of the participants prior to initiation of the trial and repeated each week of intervention. Also, dietary intake was calculated using the database Food Processor® (Version. 10.3.0.), including nutritional information of Mexican foods when they weren't on the list.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 25-50 years,
  • BMI (body mass index): under 25 kg per m2.

排除标准

  • Not smoker
  • Not have an allergy to honey
  • Not pregnant,
  • Not been previously diagnosed any disease resulting in metabolic disorders
  • Not chronically use medications known to affect metabolism
  • Not participate in greater than 3 hours of structured exercise per week.
  • Female participants that used some kind of contraceptives

结局指标

主要结局

Subject numbers that experienced change of LDL-cholesterol levels (mg/dL) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced a change of glucose level (mg/dL) post-intake of 25 g/day of honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of body fat (%) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of BMI (weight (kg)/height (m)2) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of body weight (kg) post-intake of 25 g/day honey.

时间窗: Frame: from the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of waist circumference (cm) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of triglycerides levels (mg/dL) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of total cholesterol levels (mg/dL) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of HDL-cholesterol levels (mg/dL) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of waist-hip ratio post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

Subject numbers that experienced change of hip circumference (cm) post-intake of 25 g/day honey

时间窗: From the start of treatment (baseline) until 4 weeks

次要结局

未报告次要终点

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo Hernández-Salazar

PhD. Marcelo Hernández-Salazar, Principal investigator

Universidad Autonoma de Nuevo Leon

研究点 (2)

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