NCT04153617

Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia

Nutritional and Clinical Trial to Evaluate the Effect of a Modified Honey With Soluble Fiber and Polyphenols Consumption in Subjects With Overweight/Obesity and Dyslipidemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in subjects with overweight/obesity (BMI ≥25 y \<40 kg / m2) and dyslipemia after consumption of a modifed honey with soluble fiber and polyphenols. Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. Besides, polyphenols have reported with their potent antioxidant effect and their implication lowering the vardiovascular risk.

Detailed description

The trial was designed as a randomized, parallel, double-blind and controlled study with 2 experimental arms. This study was performed to evaluate the effect on saciety and dyslipidemia of subjects with overweight/obesity after a long consumption (3 months) of a modified honey with soluble fiber and polyphenols. Additionally, a short-term randomized, cross-over, doble-blind and controlled trial was also performed to evaluate immediate saciety effect on the same subjects. For the middle-term study, investigators included 67 participants (8 men and 59 women) between 18 and 65 years (BMI ≥25 and \<40 kg / m2). All volunteers were randomized into 2 study groups, and participants received the 2 different study products during the 3 months. On the other hand, the associated short-term trial included 10 participants (5 men and 5 women) between 18 and 65 years (BMI ≥25 and \<40 kg / m2). All volunteers were randomized into 2 study groups, and participants took the 2 different study products in two non-consecutive days.

Conditions

• Overweight and Obesity
• Dyslipidemias

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Control honey	Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day)
DIETARY_SUPPLEMENT	Modified honey with soluble fiber and polyphenols	Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)

Timeline

• Start date: 2019-01-14
• Primary completion: 2019-04-19
• Completion: 2019-09-03
• First posted: 2019-11-06
• Last updated: 2019-11-06

Locations

1 site across 1 country: Spain