Obesity and Overweight
Conditions
Keywords
Clinical trials, Adult, Women, Functional food, Dietary Supplements, Overweight, Obese, Absorptiometry, Dual X-Ray, Rosmarinus, Oligosaccharides, Lactulose, Bioactive peptide
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFunctional bioactive supplement
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
DIETARY_SUPPLEMENTControl supplement
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women from 45 to 75 years old; * Overweight (IMC ≥25\<30 Kg/m2) or obese (IMC ≥30\<35 Kg/m2) volunteers * Signed informed consent.
Exclusion criteria
* Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period; * Subjects with Diabetes Mellitus insulin dependent; * Individuals that stop smoking in the next 12 weeks (during the study); * Subjects with increased alcohol consumption (\> 1 glass of vine); * Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline; * Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc; * Subjects with disorders associated with eating behaviour; * Subjects with drugs or supplements consumption to weight lost; * Subjects with physical problems complying with the recommendations of physical activity and diet indicated; * Subjects who refuse to perform the indicated dietary changes throughout the study; * Subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.); * Subjects with mental disease or low cognitive function; * Subjects with severe diseases (hepatic, kidney, cancer…); * Pregnant women or lactating; * Subjects with physical problems complying with the recommendations of physical activity. * Subjects with intensive physical activity;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body composition | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety hormones | Week 0 y Week 12 | Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY |
| Lipid profile: Cholesterol | Week 0 and Week 12 | Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides |
| Oxidative Stress Parameters | Week 0 and Week 12 | 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 |
| Adverse effects | 0 , 3, 6, 9 and 12 weeks | Adverse effects: transaminases and creatinine |
| 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 | Week 0 and Week 12 | — |
| Endothelial function markers | Week 0 y Week 12 | Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure |
| Inflammatory markers | Week 0 and Week 12 | Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen |
| Glucose Metabolism | Week 0 and Week 12 | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence and Tolerance Parameters | 0 , 3, 6, 9 and 12 weeks | Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed |
| Appetite and satiety | 0 , 3, 6, 9 and 12 weeks | — |
| Frequent daily evacuations | 4 Weeks | 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) |
Countries
Spain
Outcome results
None listed