NCT04572607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

September 9, 2020

Last Update Submit

October 1, 2020

Conditions

Healthy Subjects

Keywords

avocado honeyanthropometric parametersbiochemical parametersnatural sweetener

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (13)

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

Interventions

The consumption of avocado honey was analyzedDIETARY_SUPPLEMENT

The subjects of honey group consumed 25 g of honey each day for 4 weeks.

Honey group 1Honey group 2Honey group 3Honey group 4Honey group 5Honey group 6

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Female
  • Ages 25-50 years,
  • BMI (body mass index): under 25 kg per m2.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Salud Publica y Nutricion

Monterrey, Nuevo León, 64460, Mexico

Location

Study Officials

  • Marcelo Hernandez Salazar, PhD

    Universidad Autonoma de Nuevo Leon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Marcelo Hernández-Salazar, Principal investigator

Study Record Dates

First Submitted

September 9, 2020

First Posted

October 1, 2020

Study Start

June 1, 2019

Primary Completion

July 12, 2019

Study Completion

July 18, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

ME(1)