Healthy SubjectsNCT04572607
Effect of Avocado Honey (Apis Mellifera) on Anthropometric and Biochemical Parameters in Healthy Subjects: A Pilot Study
A study testing The consumption of avocado honey was analyzed in people with Healthy Subjects, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- The consumption of avocado honey was analyzed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2019to 18 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Female
- Ages 25-50 years,
- BMI (body mass index): under 25 kg per m2.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Facultad de Salud Publica y Nutricion
Monterrey, Nuevo León, 64460
About this 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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- The consumption of avocado honey was analyzed
- Keywords
- avocado honey, anthropometric parameters, biochemical parameters, natural sweetener
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The consumption of avocado honey was analyzedDietary supplement
The subjects of honey group consumed 25 g of honey each day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group 1 | No intervention | Not described |
| Control group 2 | No intervention | Not described |
| Control group 3 | No intervention | Not described |
| Control group 4 | No intervention | Not described |
| Control group 5 | No intervention | Not described |
| Control group 6 | No intervention | Not described |
| Control group 7 | No intervention | Not described |
| Honey group 1 | Experimental | Not described Receives: Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 2 | Experimental | Not described Receives: Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 3 | Experimental | Not described Receives: Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 4 | Experimental | Not described Receives: Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 5 | Experimental | Not described Receives: Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 6 | Experimental | Not described Receives: Dietary Supplement: The consumption of avocado honey was analyzed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject numbers that experienced a change of glucose level (mg/dL) post-intake of 25 g/day of honey
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the start of treatment (baseline) until 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Jun 2019
- Primary completion12 Jul 2019
- Study completion18 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Hernández-Salazar, Universidad Autonoma de Nuevo Leon
- Investigators
- Marcelo Hernandez Salazar, PhD, Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572607
- Sponsor's protocol ID
- 19-FaSPyN-SA-25.TP
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Avocado Honey (Apis Mellifera) on Anthropometric and Biochemical Parameters in Healthy Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT04572607
- Acronym / sponsor ID
- 19-FaSPyN-SA-25.TP
- Conditions
- Healthy Subjects
- Keywords
- avocado honey, anthropometric parameters, biochemical parameters, natural sweetener
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 18 Jul 2020 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| 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 | No intervention | – |
| Honey group 1 | Experimental | Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 2 | Experimental | Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 3 | Experimental | Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 4 | Experimental | Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 5 | Experimental | Dietary Supplement: The consumption of avocado honey was analyzed |
| Honey group 6 | Experimental | Dietary Supplement: The consumption of avocado honey was analyzed |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Female
- Ages 25-50 years,
- BMI (body mass index): under 25 kg per m2.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The consumption of avocado honey was analyzedThe subjects of honey group consumed 25 g of honey each day for 4 weeks. | Dietary supplement | Honey group 1, Honey group 2, Honey group 3, Honey group 4, Honey group 5, Honey group 6 |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Hernandez Salazar, PhD principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The consumption of avocado honey was analyzed in people with Healthy Subjects, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.