Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Intestinal flora or microbiota is the group of bacteria that live in the intestine, in a symbiotic relationship with the human body. It is estimated that human beings have around 2,000 different bacteria species. The gut microbiota plays a key in many of the body's functions. Hence, the analysis of the gut microbiome provides insight into the state of the microbiota as an indicator of overall health due to its metabolic, protective and nutritional functions. A balanced diet promotes the formation and maintenance of a well-structured microbiota, in which the different species of microorganisms cohabit in a balanced and controlled system.
The study is based on the hypothesis that the intake of certain plant-based foods rich in various active ingredients (especially non-digestible carbohydrates, certain types of fats and polyphenols) can modulate the microbiota and thus improve the health status of the human population.
Taking into account this background, the objective of this study is to assess the effect of the inclusion of functional foods and ingredients within a balanced diet on the composition of the microbiota and also on health parameters associated with metabolic disease.
The 60 volunteers participating in the study who meet the inclusion criteria, will be randomly divided into two groups:
The duration of the study are 8 weeks, during which 4 visits are scheduled:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group receiving the 4 designed foods | Experimental | The experimental group consumes the 4 foods designed for the study and will follow healthy eating guidelines. |
|
| Group with no designed foods | Active Comparator | The control group follows healthy eating guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Four-foods eating guidelines | Other | To follow a healthy eating pattern and consume four (4) foods designed for the study (extra virgin olive oil with olive leaf extract, chickpea dish with spinach, vegetable cream dish, and olive fiber) and to follow a healthy eating pattern. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of fecal microbiota composition | Measured by analyzing the variable regions V3-V4 of the prokaryotic 16S rRNA (ribosomal ribonucleic acid) gene sequences, which gives 460 bp amplicons in a two-round PCR protocol. The kit used will be the Nextera® XT DNA Index Kit, FC-131-1002 (Illumina, San Diego, CA, USA). In the first step, PCR is used to amplify a template out of a DNA fecal sample using specific primers from Illumina. Then, sequencing libraries are built with the MiSeq® Reagent Kit v3 (600 cycles) MS-102-3003 (Illumina). Finally, paired-end sequencing is performed on a MiSeq platform (Illumina) with a 600 cycles Miseq run. Fecal samples are self-collected by the volunteers' fecal samples using OMNIgene.GUT kits from DNA Genotek (Ottawa, ONT, Canada), according to the standard instructions provided by the company | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of glucose concentration | Glucose concentration will be reported in mg/dl | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of total cholesterol concentration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| FermÃn Milagro Yoldi, PhD | University of Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutrition Research. University of Navarra | Pamplona | Navarre | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003141 | Communicable Diseases |
| D009748 | Nutrition Disorders |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No designed-foods eating guidelines | Other | To follow a healthy eating pattern. Their diet is not accompanied by the four newly designed foods of the other group. |
|
Total cholesterol concentration will be reported in mg/dl
| The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of LDL-cholesterol concentration | LDL-cholesterol concentration will be reported in mg/dl by Friedewald equation. | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of HDL-cholesterol concentration | HDL-cholesterol concentration will be reported in mg/dl | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of triglyceride concentration | Triglyceride concentration will be reported in mg/dl | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of aspartate aminotransaminase concentration | Aspartate aminotransaminase concentration will be reported in mg/dl | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of alanine aminotransferase concentration | Alanine aminotransferase concentration will be reported in U/L | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of insulin concentration | Insulin concentration will be reported in U/L | Clinical The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).day 1 and 3 |
| Change of body weight | Body weight will be reported in kg | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of body mass index | Body weight will be reported in kg | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of body fat mass percentage | Body fat mass will be reported in percentage | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of body lean mass | Body lean mass will be reported in kg | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of body water percentage | Body water will be reported in percentage | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of visceral fat level | Visceral fat level will be reported | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of physical activity | Physical activity level will be monitored by physical activity questionnaire | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| Change of dietary intake | Dietary energy and macronutrient intake will be monitored by a food frequency questionnaire | The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention). |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |