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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572607
• Other study ID #: 19-FaSPyN-SA-25.TP
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 18, 2020

Study information

• Verified date: October 2020
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 18, 2020
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• The consumption of avocado honey was analyzed
The subjects of honey group consumed 25 g of honey each day for 4 weeks.

Locations

Country	Name	City	State
Mexico	Facultad de Salud Publica y Nutricion	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject numbers that experienced a change of glucose level (mg/dL) post-intake of 25 g/day of honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of triglycerides levels (mg/dL) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of total cholesterol levels (mg/dL) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of HDL-cholesterol levels (mg/dL) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of LDL-cholesterol levels (mg/dL) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of body weight (kg) post-intake of 25 g/day honey.		Frame: from the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of body fat (%) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of waist circumference (cm) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of hip circumference (cm) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of waist-hip ratio post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks
Primary	Subject numbers that experienced change of BMI (weight (kg)/height (m)2) post-intake of 25 g/day honey		From the start of treatment (baseline) until 4 weeks