Viewing Study NCT04733690



Ignite Creation Date: 2024-05-06 @ 3:44 PM
Last Modification Date: 2024-10-26 @ 1:55 PM
Study NCT ID: NCT04733690
Status: UNKNOWN
Last Update Posted: 2021-02-02
First Post: 2021-01-27

Brief Title: METABOLIC CHARACTERISTICS OF A NOVEL COMMON BEAN PRODUCT
Sponsor: Jomo Kenyatta University of Agriculture and Technology
Organization: Jomo Kenyatta University of Agriculture and Technology

Study Overview

Official Title: METABOLIC GLYCEMIC INSULINEMIC SATIETY CHARACTERISTICS OF A NOVEL COMMON BEAN Phaseolus Vulgaris L PRODUCT
Status: UNKNOWN
Status Verified Date: 2021-01
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 patients 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
Detailed Description: Type-2 diabetes T2DM in Kenya is on a rise with about 458900 people diagnosed in 2017 and a 25-fold projected increase by 2030 Prevalence of T2DM is 58 and 62 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

1 to assess the glycemic index GI of the common bean product in vivo among 10 healthy volunteers The GI of the product will be measured over a 120 min period starting at the ingestion of the common bean product Participants will be fed with an equi-carbohydrate portion of the common bean product to the reference food anhydrous glucose powder 50g or dextrose glucose monohydrate 55g The test food and reference food will be assessed in each subject on separate days with a 1 week period between each study day
2 to assess the food insulin index FII of the common bean product in vivo among 10 healthy volunteers Participants will be fed with iso-caloric 240 kilocalorie portions of the test food and reference food
3 to determine glycemic insulinemic and satiety appetite response associated with consumption of the common bean product among T2DM patients Glycemic and insulinemic response will be evaluated over a 120 min period starting at the ingestion of the common bean product Appetite scores will be used to assess the satiety power of the test product The appetite score will be assessed before and after consumption of test product at time points 0 15 30 45 60 90 and 120 minutes using short questionnaire

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None