Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia

NCT04153617 | Completed DMC

• 1 other identifier: HULP 5049
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Dyslipidemias

Keywords

Saciety; Honey; Fiber; Polyphenols; Visual Analogue Scale; Cross-over; Parallel

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Satiety Hunger Assessment

  Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line. e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.

  Day 1, 2

Secondary Outcomes (7)

• Change from Baseline Lipid Metabolism Parameters

  Week 1,12

• Amount of food consumed in a "food ad libitum"

  Day 1, 2

• Total amount of food consumed in 24h

  Day 1, 2; Week 1, 6, 12

• Change from Baseline Glucose Metabolism Parameters

  Day 1, 2; Week 1, 12

• Anthropometric Parameters

  Day 1, 2; Week 1, 12

Study Arms (2)

Control honey

PLACEBO COMPARATOR

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.

Dietary Supplement: Control honey; Dietary Supplement: Modified honey with soluble fiber and polyphenols

Modified honey with soluble fiber and polyphenols

EXPERIMENTAL

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.

Dietary Supplement: Control honey; Dietary Supplement: Modified honey with soluble fiber and polyphenols

Interventions

Control honey DIETARY_SUPPLEMENT

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

Control honey; Modified honey with soluble fiber and polyphenols

Modified honey with soluble fiber and polyphenols DIETARY_SUPPLEMENT

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

Control honey; Modified honey with soluble fiber and polyphenols

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Primo Mendoza S.L.: collaborator

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity; Dyslipidemias

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Carmen Gómez Candela, MD, Phd

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: November 6, 2019
• Study Start: January 14, 2019
• Primary Completion: April 19, 2019
• Study Completion: September 3, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)