Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia

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.

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.