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The purpose this study is to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treat obese and overweight individuals. The functional bioactive supplement, containing antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as well as to weight loss.
A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight.
Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC >25<35 kg/m2) were included in the study. The clinical trial will be performed in the Clinical Nutrition Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional bioactive supplement | Active Comparator | The functional bioactive supplement is composed of antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides. It will be used for obese and overweight treatment |
|
| Maltodextrin and saccharose | Placebo Comparator | The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional bioactive supplement | Dietary Supplement | 1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition | Clinical response - changes in body composition: weight, waist circumference and Absorptiometry, Dual X-Ray.The primary outcome result measurement was the lost weight, changes in body composition | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Life style and health status: Life style and physical activity questionnaire | Week 0 and Week 12 | |
| Genetic analysis | Week 0 and Week 12 | |
| Metabolomic analyses |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite and satiety | 0 , 3, 6, 9 and 12 weeks | |
| Frequent daily evacuations | Frequent daily evacuations, format and consistency of the feces, total and segmental transit time. The format and consistency of the feces was evaluated in accordance with the Bristol Stool Form Scale (stool are rated based on water content of the feces, with 1 meaning hard stools to 7 meaning liquid stools) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gomez Candela, PhD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | 28061 | Spain |
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| Label | URL |
|---|---|
| Institute for Health Research IdiPAZ | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000975 | Antioxidants |
| D009844 | Oligosaccharides |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Control supplement | Dietary Supplement |
|
| Week 0 and Week 12 |
| Endothelial function markers | Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure | Week 0 y Week 12 |
| Satiety hormones | Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY | Week 0 y Week 12 |
| Inflammatory markers | Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen | Week 0 and Week 12 |
| Glucose Metabolism | Glucose Metabolism: glucose, basal insulin, HbA1c (in diabetic patients), HOMA index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5) | Week 0 and Week 12 |
| Lipid profile: Cholesterol | Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides | Week 0 and Week 12 |
| Oxidative Stress Parameters | Oxidative Stress Parameters: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), oxidized LDL, PON1, F2-isoprostanes | Week 0 and Week 12 |
| Adverse effects | Adverse effects: transaminases and creatinine | 0 , 3, 6, 9 and 12 weeks |
| 4 Weeks |
| Adherence and Tolerance Parameters | Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed | 0 , 3, 6, 9 and 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020313 | Specialty Uses of Chemicals |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |