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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Control honey; Dietary supplement: Modified honey with soluble fiber and polyphenols

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Institute for Health Research IdiPAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: Control honey; Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day); Dietary supplement: Modified honey with soluble fiber and polyphenols; Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)
Experimental: 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.	Dietary supplement: Control honey; Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day); Dietary supplement: Modified honey with soluble fiber and polyphenols; Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Lipid Metabolism Parameters	Cholesterol, LDL-C, HDL-C, TG	Week 1,12
Amount of food consumed in a "food ad libitum"	120 min After eating the study product	Day 1, 2
Total amount of food consumed in 24h	24h Food Record Method	Day 1, 2; Week 1, 6, 12
Change from Baseline Glucose Metabolism Parameters	Glucose	Day 1, 2; Week 1, 12
Anthropometric Parameters	Weight and height will be combined to report BMI in kg/m2	Day 1, 2; Week 1, 12
Sensory Perception Test	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.	Day 1, 2; Week 6, 12
Adverse Effects	Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)	Day 1, 2; Week 6, 12

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Primo Mendoza S.L.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): April 19, 2019
• Study Completion (Actual): September 3, 2019

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Fiber; Polyphenols; Honey; Visual Analogue Scale; Saciety; Cross-over; Parallel
• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders; Obesity; Dyslipidemias; Overweight
• Other Study ID Numbers: HULP 5049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No