Does eating artisanal bread affect metabolism, inflammation or gut flora in people with metabolic syndrome?
| ISRCTN | ISRCTN10891611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10891611 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | RTC-2017-6467‐2 |
| Sponsor | The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain) |
| Funder | Instituto de Salud Carlos III |
- Submission date
- 30/06/2019
- Registration date
- 04/07/2019
- Last edited
- 04/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Studies from animals and using human stool samples suggests that eating bread made with yeast can improve levels of 'friendly' bacteria in the intestines, which might have effects on inflammation in that person. This study aims to investigate whether artisanal bread made using traditional methods can benefit the health of people with metabolic syndrome (a combination of early-stage diabetes, high blood pressure, and obesity) compared with standard bread produced using a high level of industrial processing.
Who can participate?
People aged 30-75 years with metabolic syndrome, which means that they have at least three of the following: high levels of fat in their blood or being treated for this condition, high levels of glucose (sugar) in their blood or being treated for this condition, high blood pressure or being treated for this condition, low levels of 'good' cholesterol, high waist measurement.
What does the study involve?
Participants will be randomly allocated to eat standard or artisanal bread for 2 months. Before the start of the intervention and after 2 months, they will fill in questionnaires related to lifestyle such as dietary habits and physical activity practice. In addition, blood and stool samples will be collected before the start and after the end of the 2-month period.
What are the possible benefits and risks of participating?
People who are gluten-intolerant will not be able to participate and it is not anticipated that there will be any risks from eating bread. People in the artisanal bread group might experience health benefits.
Where is the study run from?
Hospital del Mar Medical Research Institute (Spain)
When is the study starting and how long is it expected to run for?
April 2019 to May 2020
Who is funding the study?
Instituto de Salud Carlos III (Spain)
Who is the main contact?
Dr Montse Fitó, mfito@imim.es
Contact information
Scientific
Doctor Aiguader 88
Barcelona
08003
Spain
| 0000-0002-1817-483X | |
| Phone | 933160724 |
| mfito@imim.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Characterization and development of processes for the preparation of bread products with a positive impact on human health: Study on human models of inflammation and intestinal dysbiosis. |
| Study acronym | PrebioPa |
| Study objectives | Microbial metabolism during the fermentation of yeast dough can produce new nutritionally active compounds, such as vitamins and potentially prebiotic ex-polysaccharides. The flour breads from the grinding of the whole grain, made into yeast dough, produces a low glycemic index, because its starch is digested slowly. In addition, repeatedly low postprandial insulinemia can be an indicator of insulin sensibility, and therefore, in metabolic syndrome pathology, it can reflect an improvement of the existent insulin resistance and low grade inflammation. In addition, these artisanal breads can induce a greater satiety state in comparison with the short fermentation ones. In this regard, the low carbohydrate content in long fermentation bread, with respect to the industrial one of short fermentation, is compensated by the high fat content, which produces the energy value similar between both breads. |
| Ethics approval(s) | Approved 11/03/2019, Ethical Committee for Medicines Research of Scientific Park of Salut Mar (Dr. Aiguder 88, 08003 Barcelona, Spain; +34 93 316 06 77; ceic-psmar@imim.es), ref: 2019/8448/I |
| Health condition(s) or problem(s) studied | Metabolic syndrome |
| Intervention | A sequence from 1 to 80 was randomly assigned to group "A" or "B" by a pseudo-random number generator. In order to assure that the "A" or "B" was not concentrate at the beginning or at the end, the sequence was generated in 4 groups of 20 (10 "A" and 10 "B" in each).Participants are randomly assigned into two equal groups: A. 2-month intervention with a standard short-fermentation bread applying a fully controlled rapid fermentation in a maximum of 2 h. Participants will consume the same amount of bread as usual. B. 2-month-intervention with an Elias Boulangere yeast-dough artisanal bread with long fermentation of at least 72 h. Participants will consume the same amount of bread as usual. Both breads are comparable in terms of energy contribution, the means for each bread are the following: - standard bread: 258 kcal (1094 kJ) per 100 g - artisanal bread: 256 kcal (1086 kJ) per 100 g The project is a randomized, double blind, and parallel trial. General characteristics of the participants, educational achievement, and history of illnesses will be registered at baseline. The following data will be registered at baseline and after 2 months of intervention: physical activity, dietary habits, medication, blood pressure, and anthropometric measurements. Also, the collection of fasting blood samples and faeces will be carried out. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
The following measures will be recorded at the beginning and end of the intervention (8 weeks), for all participants: |
| Key secondary outcome measure(s) |
The following measures will be recorded at the beginning and end of the intervention (8 weeks), for all participants: |
| Completion date | 31/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 96 |
| Key inclusion criteria | 1. Aged 30-75 years 2. Meets metabolic syndrome criteria, with at least 3 of the following: 2.1. Triglycerides ≥50 mg/dl or taking medication for hypertriglyceridemia (e.g. fibrates) 2.2. Glycemia ≥100 mg/dl or taking medication to reduce it 2.3. High blood pressure, i.e. ≥130/85 mmHg or taking antihypertensive medication 2.4. HDL cholesterol <40 mg/dL in men or <50 mg/dL in women or taking medication for treatment (e.g. nicotinic acid/niacin) 2.5. Waist circumference ≥102 cm in men or ≥88 cm in women |
| Key exclusion criteria | 1. Use of antibiotics, prebiotics or probiotics 3 months before starting the study 2. Diagnosis of celiac disease 3. Diagnosis of inflammatory bowel disease (IBD) 4. History of intestinal resection 5. Any serious active disease that might prevent the participant adequately following the study 6. Alcoholism or active drug addiction 7. Use that cannot be stopped for the study of non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressant agents, antibiotics and proton pump inhibitors 8. Inability to give informed consent |
| Date of first enrolment | 04/07/2019 |
| Date of final enrolment | 29/03/2020 |
Locations
Countries of recruitment
- Spain
Study participating centre
Barcelona
08003
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/07/2019: Trial's existence confirmed by the Ethical Committee for Medicines Research of Scientific Park of Salut Mar.