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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| Göteborg University | OTHER |
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The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet (habitual diet). This will be assessed across gut microbiome profiles (high/low Prevotella), focusing on cardiometabolic risk factors, particularly inflammation.
A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will employ a three-way randomized, controlled cross-over design, featuring six-week interventions separated by six-week washout periods. Participants will attend the clinic on 15 occasions, including screening visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented plant-based foods | Experimental |
| |
| Non-fermented plant-based foods | Active Comparator |
| |
| Habitual diet | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented plant-based foods | Dietary Supplement | Participants will daily consume five different types of fermented plant-based foods, in addition to their habitual diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Investigate if glucose differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 6 weeks |
| Insulin | Investigate if insulin differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. |
| Measure | Description | Time Frame |
|---|---|---|
| The metabolome | Investigate if the fecal, blood and urine metabolome differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 6 weeks |
| Gut microbiome profiles |
Inclusion Criteria:
Waist circumference > 102 cm/88 cm M/W and at least one of the following:
Other inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rikard Landberg, PhD | Chalmers Univeristy of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital, Wallenberg Lab | Gothenburg | Ästra Götaland | 41346 | Sweden |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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A three-way randomized controlled crossover study will investigate the effects of fermented plant-based foods, non-fermented plant-based foods and the habitual diet on cardiometabolic risk factors. Each intervention will be ongoing for six weeks with six weeks washout in-between. During the fermented/non-fermented plant-based foods intervention, participants will add several corresponding food products to their habitual diet. The study has been dimensioned based on the estimated effect on hsCRP.
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| Non-fermented plant-based foods | Dietary Supplement | Participants will daily consume five different types of non-fermented plant-based foods, in addition to their habitual diet. |
|
| Habitual diet | Other | Participants will follow their habitual diet. |
|
| 6 weeks |
| Liver parameters | Investigate if liver parameters differ between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 6 weeks |
| Glycaemic variability | Investigate if glycaemic variability differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 2 weeks |
| Mixed meal tolerance test | Investigate if a mixed meal tolerance test causes different metabolic responses for the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet | 1-day |
| Gut microbiome | Investigate if the fecal microbiome differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 6 weeks |
| Blood pressure | Investigate if blood pressure differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 6 weeks |
| Blood lipid profile | Description: Investigate if c-reactive protein differs between the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 6 weeks |
Investigate if the response to the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet depends on the gut microbiome profile high/low Prevotella.
| 6 weeks |
| Transit time | Investigate if transit time, measured by intake of sweet corn, differs for the interventions fermented plant-based foods, non-fermented plant-based foods and the habitual diet. | 5-days |
| D009750 |
| Nutritional and Metabolic Diseases |