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| Name | Class |
|---|---|
| Primo Mendoza S.L. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control honey | Placebo Comparator | 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. |
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| Modified honey with soluble fiber and polyphenols | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control honey | Dietary Supplement | Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day) |
|
| 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 |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gómez Candela, MD, Phd | La Paz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Health Research IdiPAZ | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D059808 | Polyphenols |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Modified honey with soluble fiber and polyphenols | Dietary Supplement | Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day) |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |