Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia (SACIMIEL)

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Dyslipidemias; Overweight and Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04153617

HULP 5049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Control honey

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Modified honey with soluble fiber and polyphenols

Dietary Supplement: Control honey

Modified honey with soluble fiber and polyphenols

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Modified honey with soluble fiber and polyphenols

Dietary Supplement: Control honey