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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: The consumption of avocado honey was analyzed

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: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
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
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
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
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
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
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
Subject numbers that experienced change of body fat (%) post-intake of 25 g/day honey	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	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	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	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	From the start of treatment (baseline) until 4 weeks

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Nuevo Leon
• Investigators: Principal Investigator: Marcelo Hernandez Salazar, PhD, Universidad Autonoma de Nuevo Leon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): July 12, 2019
• Study Completion (Actual): July 18, 2020

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 26, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: biochemical parameters; avocado honey; anthropometric parameters; natural sweetener
• Other Study ID 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