Back to resultsEffect of Yoghurts Enriched With XXS (Mixture of Natural Polyphenolic Compounds and Plant Extracts) on the Evolution of Weight in Overweight Subjects (VITALIM Senior)
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
yoghurts enriched with XXS
yoghurts non enriched with XXS
Sponsored by
About this trial
This is an interventional other trial for Obesity
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) .
Sites / Locations
- Hôpital Champmaillot Geriatric Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
yoghurts enriched with XXS
yoghurts non enriched with XXS
Arm Description
Outcomes
Primary Outcome Measures
Bodyweight
Secondary Outcome Measures
Full Information
NCT ID
NCT02810041
First Posted
June 20, 2016
Last Updated
January 8, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02810041
Brief Title
Effect of Yoghurts Enriched With XXS (Mixture of Natural Polyphenolic Compounds and Plant Extracts) on the Evolution of Weight in Overweight Subjects
Acronym
VITALIM Senior
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 17, 2014 (Actual)
Primary Completion Date
May 27, 2015 (Actual)
Study Completion Date
May 27, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
yoghurts enriched with XXS
Arm Type
Experimental
Arm Title
yoghurts non enriched with XXS
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
yoghurts enriched with XXS
Intervention Type
Dietary Supplement
Intervention Name(s)
yoghurts non enriched with XXS
Primary Outcome Measure Information:
Title
Bodyweight
Time Frame
Change from baseline bodyweight at day 60, day100 at 105 in the two groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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) .
Facility Information:
Facility Name
Hôpital Champmaillot Geriatric Department
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Yoghurts Enriched With XXS (Mixture of Natural Polyphenolic Compounds and Plant Extracts) on the Evolution of Weight in Overweight Subjects
We'll reach out to this number within 24 hrs