Clinical trial NCT04153617: Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Dyslipidemias
Keywords: Saciety
Honey
Fiber
Polyphenols
Visual Analogue Scale
Cross-over
Parallel
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Primo Mendoza S.L.
First posted: 2019-11-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change from Baseline Satiety Hunger Assessment
timeFrame: Day 1, 2
Secondary outcomes:
measure: Change from Baseline Lipid Metabolism Parameters
timeFrame: Week 1,12
measure: Amount of food consumed in a "food ad libitum"
timeFrame: Day 1, 2
measure: Total amount of food consumed in 24h
timeFrame: Day 1, 2; Week 1, 6, 12
measure: Change from Baseline Glucose Metabolism Parameters
timeFrame: Day 1, 2; Week 1, 12
measure: Anthropometric Parameters
timeFrame: Day 1, 2; Week 1, 12
measure: Sensory Perception Test
timeFrame: Day 1, 2; Week 6, 12
measure: Adverse Effects
timeFrame: Day 1, 2; Week 6, 12
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: La Paz University Hospital
name: Carmen Gómez Candela, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: