Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia

NCT ID: NCT04153617

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2019-09-03

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control honey

Orange blossom honey.

Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day.

Short term trial: 20g/day in a single day.

Group Type: PLACEBO_COMPARATOR

Control honey

Intervention Type: DIETARY_SUPPLEMENT

Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day)

Modified honey with soluble fiber and polyphenols

Intervention Type: DIETARY_SUPPLEMENT

Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)

Modified honey with soluble fiber and polyphenols

Honey modified with soluble fiber and polyphenols

Middle term trial: 40g/day for 3 months in two daily intakes of 20 g/day.

Short term trial: 20g/day in a single day.

Group Type: EXPERIMENTAL

Control honey

Intervention Type: DIETARY_SUPPLEMENT

Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day)

Modified honey with soluble fiber and polyphenols

Intervention Type: DIETARY_SUPPLEMENT

Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)

Interventions

Control honey

Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day)

Intervention Type: 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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Men and women from 18 to 65 years old.
• Body Mass Index (BMI) ≥25 and <40 kg/m2.
• Cardiovascular risk <10% to 10 years measured by REGICOR.
• Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:

• ≥ 45 years or women ≥ 55 years.
• Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
• HDL cholesterol: men <40 or women <50.
• Triglycerides ≥ 150mg/dL and <200 mg/dL
• LDL cholesterol ≥ 130mg/dL and < 160mg/dL
• Smoker
• Willingness to follow a healthy and balanced hypocaloric diet with mandatory physical activity
• Social or familiar environment that prevents from accomplishing the dietary treatment
• Adequate cultural level and understanding for the clinical trial.
• Signed informed consent

Exclusion Criteria

• Body Mass Index (BMI) <25 and ≥40 kg/m2.
• Individuals diagnosed with Diabetes Mellitus type 1 or 2.
• Individuals with dyslipidemia on pharmacological treatment.
• Individuals with hypertension on pharmacological treatment.
• Individuals diagnosed with eating disorders.
• Individuals fructose-intolerant.
• Individuals with a diagnosis of celiac disease or a gluten intolerance.
• Individuals with severe chronic diseases (hepatic, kidney, …)
• Individuals receiving a pharmacological treatment that modifies the lipid or glucose profile.
• Individuals who have participated in the last 3 months in a program or clinical trial to lose weight.
• Individuals with mental illness.
• Smokers wanting to stop to smoke during the period that clinical trial lasts.
• Individuals with high alcohol consumption (> 2-3 servings/ day in men and> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer).
• Individuals with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet.
• Individuals with sensory problems.
• Individuals with gastrointestinal diseases that affect the digestion or absorption of nutrients.
• Individuals under pharmacological treatment for losing weight unless treatment is suspended 30 days before the start of the trial.
• Subjects with intense physical activity.
• Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
• Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Primo Mendoza S.L.

UNKNOWN

Sponsor Role: collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Gómez Candela, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

La Paz University Hospital

Locations

Institute for Health Research IdiPAZ

Madrid, , Spain

Countries

Spain

Other Identifiers

HULP 5049

Identifier Type: -

Identifier Source: org_study_id