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Clinical Trial Summary

Obesity is considered the epidemic of the 21st century. Obesity is a multifactorial disease and the most important risk factors are poor diet and sedentary lifestyle. An excessive body weight contributes to increase the risk of suffering from other diseases and mortality rates. Therefore, the prevention and control of excessive body weight as well as its comorbidities are essential. In this sense, the principal strategy to treat obesity is to improve dietary habits and increase physical activity. However, the rate of obesity continues rising. In order to deal with this problem, new strategies to combat obesity are being investigated, such as the investigation of new bioactive compounds with satiating capacity that can be included in healthy dietary patterns to improve adherence to dietary treatments. Considering this background, the main objective of this research is to assess the effect of daily consumption of protein rich bars accompanied by healthy dietary recommendations on weight loss of overweight/obese adult men and women.


Clinical Trial Description

This study is designed as a 12-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old. All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research in the University of Navarra for the screening visit and 4 more times during the intervention (week 1, 4, 8 and 12 of study). Screening visit: evaluation of the inclusion criteria. Volunteers who meet the inclusion criteria are provided with a feces collection kit, urine collection kit, food frequency questionnaire, visual analogue scale and minnesota physical activity questionnaire. Moreover, they are randomly assigned to one of the two intervention groups: - Control group: healthy dietary recommendations. - Experimental group: healthy dietary recommendations + 2 protein rich bars/day Clinical investigation day 1 (week 1): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in screening visit. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. After that, volunteer is provided with healthy dietary recommendations only or dietary recommendations and protein rich bars, depending on the allocated intervention group. Moreover, volunteer is provided with visual analogue scale to be completed for the Clinical investigation day 2. Clinical investigation day 2 (week 4): The volunteer attend the Nutrition Intervention Unit. The volunteer is asked to provide the visual analogue scale. Then, gastrointestinal symptoms questionnaire is completed and the adherence to the study is assessed. Then, body weight and blood pressure are measured. Volunteer is provided with fece and urine collection kits, food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale, to be completed for the Clinical investigation day 3. Finally, volunteers allocated in experimental group are provided with protein rich bars. Clinical investigation day 3 (week 8): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 2. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. Volunteer is provided with fece and urine collection kits, as well as food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale to be completed for the Clinical investigation day 4. Finally, volunteers allocated in experimental group are provided with protein rich bars. Clinical investigation day 4 (week 12): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 3. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05368311
Study type Interventional
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact
Status Active, not recruiting
Phase N/A
Start date February 11, 2022
Completion date August 30, 2022

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