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

NCT ID: NCT04572607

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-07-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group 1

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 2

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 3

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 4

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 5

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 6

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 7

Group Type NO_INTERVENTION

No interventions assigned to this group

Honey group 1

Group Type EXPERIMENTAL

The consumption of avocado honey was analyzed

Intervention Type DIETARY_SUPPLEMENT

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

Honey group 2

Group Type EXPERIMENTAL

The consumption of avocado honey was analyzed

Intervention Type DIETARY_SUPPLEMENT

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

Honey group 3

Group Type EXPERIMENTAL

The consumption of avocado honey was analyzed

Intervention Type DIETARY_SUPPLEMENT

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

Honey group 4

Group Type EXPERIMENTAL

The consumption of avocado honey was analyzed

Intervention Type DIETARY_SUPPLEMENT

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

Honey group 5

Group Type EXPERIMENTAL

The consumption of avocado honey was analyzed

Intervention Type DIETARY_SUPPLEMENT

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

Honey group 6

Group Type EXPERIMENTAL

The consumption of avocado honey was analyzed

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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The consumption of avocado honey was analyzed

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role lead

Responsible Party

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Marcelo Hernández-Salazar

PhD. Marcelo Hernández-Salazar, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcelo Hernandez Salazar, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonoma de Nuevo Leon

Locations

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Facultad de Salud Publica y Nutricion

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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19-FaSPyN-SA-25.TP

Identifier Type: -

Identifier Source: org_study_id

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