Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults
Condition: Obesity; Weight Loss; Protein
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Dietary recommendations including protein enriched bars; Dietary recommendations without protein enriched bars
Intervention type(s): Other; Other
Intervention description(s): Volunteers allocated in the experimental group will receive dietary recommendations and 2 protein enriched bars per day to be eaten 45 minutes before lunch and dinner.; Volunteers allocated in the experimental group will receive dietary recommendations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Protein; Weight loss; Obesity; Overweight; Satiety