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

October 1, 2020 updated by: Marcelo Hernández-Salazar, Universidad Autonoma de Nuevo Leon
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Facultad de Salud Publica y Nutricion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group 1
No Intervention: Control group 2
No Intervention: Control group 3
No Intervention: Control group 4
No Intervention: Control group 5
No Intervention: Control group 6
No Intervention: Control group 7
Experimental: Honey group 1
Dietary supplement: The consumption of avocado honey was analyzed
The subjects of honey group consumed 25 g of honey each day for 4 weeks.
Experimental: Honey group 2
Dietary supplement: The consumption of avocado honey was analyzed
The subjects of honey group consumed 25 g of honey each day for 4 weeks.
Experimental: Honey group 3
Dietary supplement: The consumption of avocado honey was analyzed
The subjects of honey group consumed 25 g of honey each day for 4 weeks.
Experimental: Honey group 4
Dietary supplement: The consumption of avocado honey was analyzed
The subjects of honey group consumed 25 g of honey each day for 4 weeks.
Experimental: Honey group 5
Dietary supplement: The consumption of avocado honey was analyzed
The subjects of honey group consumed 25 g of honey each day for 4 weeks.
Experimental: Honey group 6
Dietary supplement: The consumption of avocado honey was analyzed
The subjects of honey group consumed 25 g of honey each day for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Time Frame: From the start of treatment (baseline) until 4 weeks
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
Time Frame: From the start of treatment (baseline) until 4 weeks
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
Time Frame: From the start of treatment (baseline) until 4 weeks
From the start of treatment (baseline) until 4 weeks
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
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.
Time Frame: Frame: from the start of treatment (baseline) until 4 weeks
Frame: from the start of treatment (baseline) until 4 weeks
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
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
Time Frame: From the start of treatment (baseline) until 4 weeks
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
Time Frame: From the start of treatment (baseline) until 4 weeks
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
Time Frame: From the start of treatment (baseline) until 4 weeks
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
Time Frame: From the start of treatment (baseline) until 4 weeks
From the start of treatment (baseline) until 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Nuevo Leon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcelo Hernandez Salazar, PhD, Universidad Autonoma de Nuevo Leon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-FaSPyN-SA-25.TP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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