Effect of Yoghurts Enriched With XXS (Mixture of Natural Polyphenolic Compounds and Plant Extracts) on the Evolution of Weight in Overweight Subjects

NCT ID: NCT02810041

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-17
• Study Completion Date: 2015-05-27

Brief Summary

Overweight and obesity are public health problems worldwide. Even though heredity may be one of the causes the diseases, the vast majority of cases is rather linked to a sedentary lifestyle associated or not with a low-variety, high-calorie diet. Many diets and slimming methods propose low-calorie meals or physical exercise, and the consequences of these are sometimes negative with advancing age (muscle wasting). Certain studies have shown the efficacy of foods with antioxidant properties on the reduction of blood pressure, Low Density Lipoprotein (LDL)-cholesterol and weight or on the distribution of fat mass-lean mass. The investigators put forward the hypothesis that the daily consumption of two yoghurts containing XXS, a mixture of natural polyphenolic compounds -rich in quercetin- from plant extracts, could lead to weight loss, a better fat mass-lean mass distribution and an improvement in markers of oxidative stress in overweight persons aged 50 to 65 years.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

yoghurts enriched with XXS

Group Type: EXPERIMENTAL

yoghurts enriched with XXS

Intervention Type: DIETARY_SUPPLEMENT

yoghurts non enriched with XXS

Group Type: PLACEBO_COMPARATOR

yoghurts non enriched with XXS

Intervention Type: DIETARY_SUPPLEMENT

Interventions

yoghurts enriched with XXS

Intervention Type: DIETARY_SUPPLEMENT

yoghurts non enriched with XXS

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Men or women aged between 50 and 65 years;
• who have provided written consent;
• and are covered by national health insurance;
• with a stable weight for 6 months and no intention to begin a diet in the coming three months;
• with a Body Mass Index (BMI) between 25 and 29.9 kg/m2 and a waist circumference > 80 cm in women and > 94cm in men (thresholds of the International Diabetes Federation, IDF);
• who consume dairy products such as yoghurts;
• and do not have more than two of the following risk factors of metabolic syndrome: known history of hypertension (>130/85mmHg), hypocholesterolemia High Density Lipoprotein HDL (< 0.4 g/L men and 0.5 g/L women), hypertriglyceridemia (>1.5 g/L), diabetes (> 1.1 g/L);
• presenting C Reactive Protein (CRP) < 6mg/L.

Exclusion Criteria

• adults under guardianship
• persons following a prescribed of self-prescribed diet;
• whose behaviour may interfere with the consumption of the active dairy product (more than 4h of physical activity a week, smoking more than 10 cigarettes a day, more than 2 glasses of alcohol a day, Consuming more than one bar of dark chocolate a day, 10 cups of coffee/day, 5 large cups of tea/day, supplementation with vitamins (A, C, E…), oligoelements or minerals (Se, Zn, Ca…), enriched dairy products or any supplements containing Dietary Foods for Specialized Medical Purposes (ADFMS) .

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Champmaillot Geriatric Department

Dijon, , France

Countries

France

Other Identifiers

VAN WYMELBEKE SENOBLE 2013

Identifier Type: -

Identifier Source: org_study_id