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

NCT02810041 | Completed

• 1 other identifier: VAN WYMELBEKE SENOBLE 2013
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bodyweight

  Change from baseline bodyweight at day 60, day100 at 105 in the two groups

Study Arms (2)

yoghurts enriched with XXS

EXPERIMENTAL

Dietary Supplement: yoghurts enriched with XXS

yoghurts non enriched with XXS

PLACEBO COMPARATOR

Dietary Supplement: yoghurts non enriched with XXS

Interventions

yoghurts enriched with XXS DIETARY_SUPPLEMENT

yoghurts enriched with XXS

yoghurts non enriched with XXS DIETARY_SUPPLEMENT

yoghurts non enriched with XXS

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) .

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Hôpital Champmaillot Geriatric Department

Dijon, 21079, France

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: November 17, 2014
• Primary Completion: May 27, 2015
• Study Completion: May 27, 2015
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

FR (1)