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

Randomized Controlled Double-blind Clinical Trial for the Effect of Yoghurts Enriched in XXS vs Without XXS on the Evolution of Weight in Overweight Subjects Aged 50 to 65 Years.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: yoghurts enriched with XXS; Dietary supplement: yoghurts non enriched with XXS

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Hôpital Champmaillot Geriatric Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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) .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: yoghurts enriched with XXS	Dietary supplement: yoghurts enriched with XXS
Placebo Comparator: yoghurts non enriched with XXS	Dietary supplement: yoghurts non enriched with XXS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bodyweight	Change from baseline bodyweight at day 60, day100 at 105 in the two groups

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2014
• Primary Completion (Actual): May 27, 2015
• Study Completion (Actual): May 27, 2015

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: VAN WYMELBEKE SENOBLE 2013