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Completed

NCT Number: NCT04572607

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

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.

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Key information

Conditions

Healthy Subjects

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Salud Publica y Nutricion

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

The consumption of avocado honey was analyzed

Dietary Supplement

The subjects of honey group consumed 25 g of honey each day for 4 weeks.

Primary outcomes

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: Frame: from the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

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

    Time frame: From the start of treatment (baseline) until 4 weeks

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 1, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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