Clinical trial NCT04572607: Effect of Avocado Honey (Apis Mellifera) on Anthropometric and Biochemical Parameters in Healthy Subjects: A Pilot Study
Official title: Effect of Avocado Honey (Apis Mellifera) on Anthropometric and Biochemical Parameters in Healthy Subjects: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: avocado honey
anthropometric parameters
biochemical parameters
natural sweetener
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 13
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subject numbers that experienced a change of glucose level (mg/dL) post-intake of 25 g/day of honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of triglycerides levels (mg/dL) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of total cholesterol levels (mg/dL) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of HDL-cholesterol levels (mg/dL) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of LDL-cholesterol levels (mg/dL) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of body weight (kg) post-intake of 25 g/day honey.
timeFrame: Frame: from the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of body fat (%) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of waist circumference (cm) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of hip circumference (cm) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of waist-hip ratio post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
measure: Subject numbers that experienced change of BMI (weight (kg)/height (m)2) post-intake of 25 g/day honey
timeFrame: From the start of treatment (baseline) until 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Facultad de Salud Publica y Nutricion
state: Nuevo Leon
Study officials:
affiliation: Universidad Autonoma de Nuevo Leon
name: Marcelo Hernandez Salazar, PhD
role: PRINCIPAL_INVESTIGATOR
References: