Hospital Universitario La Paz
Madrid, 28061, Spain
NCT Number: NCT02024425
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.
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Notify Me18 year–65 year
Female
Interventional
Phase 4
Madrid, 28061, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Other names: antioxidant, oligosaccharides and bioactive peptides
Time frame: 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
Time frame: Week 0 and Week 12
Time frame: Week 0 and Week 12
Time frame: Week 0 and Week 12
Time frame: Week 0 y Week 12
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Time frame: Week 0 y Week 12
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Time frame: Week 0 and Week 12
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
Time frame: 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)
Time frame: Week 0 and Week 12
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
Time frame: 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
Time frame: 0 , 3, 6, 9 and 12 weeks
Adverse effects: transaminases and creatinine
Time frame: 0 , 3, 6, 9 and 12 weeks
Time frame: 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)
Time frame: 0 , 3, 6, 9 and 12 weeks
Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
Instituto de Investigación Hospital Universitario La Paz
Other
A Randomized, Double-blind Trial to Evaluate the Effect of a Functional Bioactive Supplement Associated With a Hypocaloric Equilibrated Diet to Treatment of Obese and Overweight Individuals
Acronym: ALIBIRDII
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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