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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| Legumes Centre of Excellence for Food and Nutrition Security | UNKNOWN |
| VLIR-UOS | UNKNOWN |
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Kenya is classified as having three main forms of malnutrition (overweight, anaemia and stunting), exhibiting a double burden of malnutrition nutritional landscape. Trends from the 80s to present show that indicators of overweight and obesity, and diabetes in both adult men and women either show no progress or are worsening. It is a chronic inflammatory metabolic disease occurring when the pancreas is unable to produce sufficient amounts of insulin or when the body cannot effectively utilize produced insulin or both.
Given that T2DM impacts on several aspects of a patient's quality of life, functionality, and health status, finding effective dietary strategies to combat this condition is key. In diabetes patients, low-glycemic index foods rich in dietary fibre, vitamins, and minerals should be encouraged. Common beans are an important source of iron and zinc. Common beans contain slowly digestible carbohydrates and a high proportion of non-digestible carbohydrates. Fibre (soluble and non-soluble) in beans would be beneficial to T2DM patients by reducing macronutrient absorption, satiety increase, increased sensibility to insulin, effects on inflammatory markers and on intestinal microbiota. Moreover, they contain several bioactive compounds possessing anti-inflammatory, antioxidant and other biological activity. Due to their composition and effects, common beans have attractive properties for T2DM patients. The common bean predominates other legumes in terms of production in Africa. The aim of this research is to study the associated glucose, insulin and appetite responses associated with the consumption of a novel common bean product.
Type-2 diabetes (T2DM) in Kenya is on a rise with about 458,900 people diagnosed in 2017 and a 2.5-fold projected increase by 2030. Prevalence of T2DM is 5.8% and 6.2% in men and women. T2DM has an inflammatory disease character and is characterized by hyperglycemia. Common beans in T2DM patients could have many health benefits such as modulation of glucose metabolism, reduction of low-density lipoproteins, and satiety.
In this research, we develop a food-grade novel common bean product from food-grade ingredients though the application of conventional food processing technologies. We will then assess postprandial insulin, blood glucose and appetite responses associated with consumption of the common bean product in healthy volunteers and T2DM patients. The specific aims of our research are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers (Glycemic Index) | The glycemic index (GI) of the common bean product will be assessed in this cohort among 10 study participants. The GI of the product will be assessed on 3 test days over a 120 min period on each study day. |
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| Healthy Volunteers(Food Insulin Index) | The food insulin index (FII) of the common bean product will be assessed in this cohort among 10 study participants. This study will recruit 10 participants. The FII of the product will be assessed on 3 test days over a 120 min period on each study day. |
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| Type-2 diabetes (T2DM) patients | Glycemic, insulinemic and satiety responses associated with the consumption of the common bean product will be assessed in this cohort among 10 T2DM patients. Participants will attend one study visit lasting approximately 120 min. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Common bean product | Dietary Supplement | Healthy volunteers Healthy volunteers in the GI and FII studies will participate in the study during 3 test days for each of the studies. The reference food will be tested 2 times and the test food 1 time in each participant. T2DM patients T2DM patients will participate in the study for one test day for the assessment of postprandial glycemic, insulinemic and satiety responses. For both healthy volunteers and T2DM patients, the following will be assessed during study days: 24-hour of dietary recall; weight, height, waist and hip circumferences; blood pressure; and body composition using bioelectrical impedance analysis (BIA). Participants will be fed with a portion of the test or reference food and 250ml water. Two fasting blood samples (-5 and 0 min) and postprandial blood samples (15, 30, 45, 60, 90 and 120 min) will be collected |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic response | The effect associated with consumption of the common bean product on blood sugar (glucose) levels. | 120 min |
| Insulinemic response | The effect associated with consumption of the common bean product on insulin levels. | 120 min |
| Satiety | Appetite score refers to the average between hunger, desire to eat, prospective consumption and a 100-fullness score. | 120 min |
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Inclusion Criteria:
Healthy volunteers (incl. criteria)
T2DM patients (incl. criteria)
Exclusion Criteria:
Healthy volunteers (excl. criteria)
T2DM patients (excl. criteria)
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Healthy volunteers The healthy volunteers will be recruited from Jomo Kenyatta University of Agriculture and Technology (JKUAT) and handled at the JKUAT University Hospital.
T2DM patients The participants will be recruited from the Makueni Level-5 and Mbooni sub-county hospitals which run a diabetes outpatient clinic.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | ISO, "ISO 26642:2010(en), Food products - Determination of the glycaemic index (GI) and recommendation for food classification," 2010. [Online]. Available: https://www.iso.org/obp/ui/#iso:std:iso:26642:ed-1:v1:en. [Accessed: 04-Jul-2019]. |
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Individual participant data will be stored by the principal investigators. A controlled access approach, allowing for review of requests will be used to provide secure data access. Study findings will be published in peer-reviewed journals and also presented in conferences, research seminars and workshops through oral or poster presentations after completion of this study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 31, 2020 | Jan 27, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Blood sample
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| D004700 | Endocrine System Diseases |