Clinical trial NCT05368311: Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults
Official title: Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Protein
Keywords: Protein
Weight loss
Obesity
Overweight
Satiety
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Volunteers with BMI between 24.9 and 34.9 kg/m2.
* Physical examination and vital signs normal or clinically irrelevant to the study.
* Volunteers undergoing pharmacological treatment will be included if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function and antidiabetics.
* Subjects must be able to understand and be willing to sign the informed consent, as well as comply with all the procedures and requirements of the study.
* Present a stable weight (+/-3kg) in the last three months before the start of the study.

Exclusion Criteria:

* Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
* Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
* Women who are breastfeeding or pregnant.
* Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
* Subjects with liver disease.
* Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
* Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
* Subjects who present some type of cognitive and/or psychic impairment.
* Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
* Subjects who work night shifts.
* Subjects who follow some type of supplementation that interferes with the study.
* Subjects who are immersed in some treatment for weight loss.

Primary outcomes:
measure: Change of weight from baseline to week 4 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of weight from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of weight from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of weight from week 4 to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 3(after 8 weeks of intervention).
measure: Change of weight from week 4 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of weight from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Secondary outcomes:
measure: Change of body fat percentage from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body fat percentage from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body fat percentage from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body fat kilograms from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body fat kilograms from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body fat kilograms from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body muscle mass from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body muscle mass from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body muscle mass from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body lean mass from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body lean mass from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body lean mass from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body water mass from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body water mass from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body water mass from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body water percentage from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body water percentage from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body water percentage from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mass from baseline to week 8 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of bone mass from baseline to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mass from week 8 to week 12 (bioimpedance)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Height at baseline
timeFrame: The Time Frame contains one time point: screening visit.
measure: Change of waist circumference from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of waist circumference from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of waist circumference from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of hip circumference from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of hip circumference from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of hip circumference from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of neck circumference from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of neck circumference from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of neck circumference from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of systolic blood pressure from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of systolic blood pressure from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of systolic blood pressure from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of systolic blood pressure from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of systolic blood pressure from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of diastolic blood pressure from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of diastolic blood pressure from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of diastolic blood pressure from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of diastolic blood pressure from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of diastolic blood pressure from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of heart rate from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of heart rate from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of heart rate from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of heart rate from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of heart rate from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body fat mass in percentage from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body fat mass in percentage from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body fat mass in percentage from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body fat mass in kg from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of body fat mass in kg from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of body fat mass in kg from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of lean mass in kg from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of lean mass in kg from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of lean mass in kg from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of lean mass in kg from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral concentration from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of bone mineral concentration from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral concentration from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral density from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of bone mineral density from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral density from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of visceral mass from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of visceral mass from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of visceral mass from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of L1-L4 bone mineral density from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of L1-L4 bone mineral density from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of L1-L4 bone mineral density from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of total bone mineral density of femur from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of total bone mineral density of femur from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of total bone mineral density of femur from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral density of femur neck from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of bone mineral density of femur neck from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral density of femur neck from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral density of radius from baseline to week 8 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of bone mineral density of radius from baseline to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bone mineral density of radius from week 8 to week 12 (densitometry)
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of glucose concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of glucose concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of glucose concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of total cholesterol concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of total cholesterol concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of total cholesterol concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of HDL cholesterol concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of HDL cholesterol concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of HDL cholesterol concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of LDL cholesterol concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of LDL cholesterol concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of LDL cholesterol concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of triglyceride concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of triglyceride concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of triglyceride concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of alanine aminotransferase concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of alanine aminotransferase concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of alanine aminotransferase concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of aspartate aminotransferase concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of aspartate aminotransferase concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of aspartate aminotransferase concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of homocysteine concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of homocysteine concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of homocysteine concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of C-reactive protein concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of C-reactive protein concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of C-reactive protein concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of hemogram concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of hemogram concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of hemogram concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of albumin concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of albumin concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of albumin concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of creatinine concentration from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 8 weeks of intervention).
measure: Change of creatinine concentration from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of creatinine concentration from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of physical activity level from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of physical activity level from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of physical activity level from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of dietary intake from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of dietary intake from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of dietary intake from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of hunger from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of hunger from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of hunger from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of hunger from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of hunger from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of fullness from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of fullness from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of fullness from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of fullness from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of fullness from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of satisfaction sensation from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of satisfaction sensation from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of satisfaction sensation from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of satisfaction sensation from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of satisfaction sensation from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of want to eat something else sensation from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of want to eat something else sensation from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of want to eat something else sensation from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of want to eat something else sensation from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of want to eat something else sensation from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of thirst sensation from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of thirst sensation from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of thirst sensation from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of thirst sensation from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of thirst sensation from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of gastrointestinal symptoms from baseline to week 4
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of gastrointestinal symptoms from baseline to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of gastrointestinal symptoms from baseline to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of gastrointestinal symptoms from week 4 to week 8
timeFrame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of gastrointestinal symptoms from week 8 to week 12
timeFrame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Bar acceptance at week 12
timeFrame: The Time Frame contains Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bar consumption record from baseline to week 4
timeFrame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
measure: Change of bar consumption record from baseline to week 8
timeFrame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of bar consumption record from baseline to week 12
timeFrame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change of bar consumption record from week 4 to week 8
timeFrame: The Time Frame contains Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change of bar consumption record from week 8 to week 12
timeFrame: The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change in urine and feces hydroxyproline concentration from baseline to week 8
timeFrame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
measure: Change in urine and feces hydroxyproline concentration from baseline to week 12
timeFrame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
measure: Change in urine and feces hydroxyproline concentration from week 8 to week 12
timeFrame: The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Center for Nutrition Research. University of Navarra
state: Navarra
Study officials:
affiliation: Center for Nutrition Research, University of Navarra.
name: María Ángeles Zulet, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Nutrition Research, University of Navarra.
name: Carlos J González Navarro, PhD
role: STUDY_CHAIR
affiliation: Center for Nutrition Research, University of Navarra.
name: Fermín I Milagro Yoldi, PhD
role: STUDY_CHAIR
affiliation: Center for Nutrition Research, University of Navarra.
name: Idoia Ibero Baraibar, PhD
role: STUDY_CHAIR
affiliation: Center for Nutrition Research, University of Navarra.
name: Itziar Abete Goñi, PhD
role: STUDY_CHAIR
affiliation: Center for Nutrition Research, University of Navarra.
name: Miguel López Yoldi, PhD
role: STUDY_CHAIR
References: