Enriched Honey With Soluble Fiber and Polyphenols on Satiety and Dyslipidemia

Not Applicable

Completed

• Conditions: Dyslipidemias; Overweight and Obesity
• Interventions: Dietary Supplement: Control honey; Dietary Supplement: Modified honey with soluble fiber and polyphenols

• Registration Number: NCT04153617
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2019-01-14
• Primary Completion: 2019-04-19
• Status Verified: 2019-09
• Study Completion: 2019-09-03
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-11-05
• Last Update Submitted: 2019-11-05
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified honey with soluble fiber and polyphenols	Control honey	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.
Control honey	Modified honey with soluble fiber and polyphenols	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.
Control honey	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.
Modified honey with soluble fiber and polyphenols	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Satiety Hunger Assessment	Day 1, 2	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Lipid Metabolism Parameters	Week 1,12	Cholesterol, LDL-C, HDL-C, TG
Change from Baseline Glucose Metabolism Parameters	Day 1, 2; Week 1, 12	Glucose
Anthropometric Parameters	Day 1, 2; Week 1, 12	Weight and height will be combined to report BMI in kg/m2
Amount of food consumed in a "food ad libitum"	Day 1, 2	120 min After eating the study product
Total amount of food consumed in 24h	Day 1, 2; Week 1, 6, 12	24h Food Record Method
Sensory Perception Test	Day 1, 2; Week 6, 12	Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.
Adverse Effects	Day 1, 2; Week 6, 12	Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain