METABOLIC CHARACTERISTICS OF A NOVEL COMMON BEAN PRODUCT

NCT04733690 | Unknown

• 1 other identifier: P751-2020
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Type 2 Diabetes

Keywords

Phaseolus vulgaris L.; Glycemic Index; Food Insulin Index; Appetite; Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

Dietary Supplement: Common bean product

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.

Dietary Supplement: Common bean product

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.

Dietary Supplement: Common bean product

Interventions

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

Healthy Volunteers (Glycemic Index); Healthy Volunteers(Food Insulin Index); Type-2 diabetes (T2DM) patients

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Healthy volunteers (incl. criteria)
• Male or female 18-69 years
• No known food allergies or intolerances
• No prescription medication (excluding oral contraceptives) known to affect glucose intolerance (e.g. steroids, protease inhibitors, antipsychotics e.t.c.)
• T2DM patients (incl. criteria)
• Male or female aged 18-69 years
• Previously diagnosed with type 2 diabetes
• Consenting to participate

You may not qualify if:

• Healthy volunteers (excl. criteria)
• Known history of diabetes mellitus or use of anti-hyperglycaemic medication or insulin
• Alcohol or tobacco use in the evening preceding the test
• Vigorous exercise on the morning of the test
• Undergone major medical/surgical event needing hospitalization within the preceding 3 months
• Presence of disease or drug influencing digestion and absorption of medicine
• T2DM patients (excl. criteria)
• Use of prescription medication
• History of eating disorders and irregular eating habits
• Use of tobacco or alcohol
• Females experiencing menstrual period or adverse premenstrual symptoms

Sponsors & Collaborators

• Jomo Kenyatta University of Agriculture and Technology: lead
• KU Leuven: collaborator
• Legumes Centre of Excellence for Food and Nutrition Security: collaborator
• VLIR-UOS: collaborator

Related Publications (1)

• 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].

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senor Lecturer

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: February 4, 2021
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share