Type 2 DiabetesNCT04733690
METABOLIC CHARACTERISTICS OF A NOVEL COMMON BEAN PRODUCT
An observational study of Type 2 Diabetes, run by Jomo Kenyatta University of Agriculture and Technology.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Common bean product
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2021to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: METABOLIC (GLYCEMIC, INSULINEMIC & SATIETY) CHARACTERISTICS OF A NOVEL COMMON BEAN (Phaseolus Vulgaris L.) PRODUCT
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.
Read the detailed description
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:
- 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.
- 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.
- 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Common bean product
- Keywords
- Phaseolus vulgaris L., Glycemic Index, Food Insulin Index, Appetite, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common bean productDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Common bean product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
The effect associated with consumption of the common bean product on blood sugar (glucose) levels.
Measured: 120 min
Insulinemic response
The effect associated with consumption of the common bean product on insulin levels.
Measured: 120 min
Satiety
Appetite score refers to the average between hunger, desire to eat, prospective consumption and a 100-fullness score.
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start4 Feb 2021 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jomo Kenyatta University of Agriculture and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Legumes Centre of Excellence for Food and Nutrition Security, VLIR-UOS
- Responsible party
- Principal investigator, Dr. Florence Kyallo, Jomo Kenyatta University of Agriculture and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733690
- Sponsor's protocol ID
- P751-2020
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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].
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METABOLIC (GLYCEMIC, INSULINEMIC & SATIETY) CHARACTERISTICS OF A NOVEL COMMON BEAN (Phaseolus Vulgaris L.) PRODUCT
- ClinicalTrials.gov ID
- NCT04733690
- Acronym / sponsor ID
- P751-2020
- Conditions
- Type 2 Diabetes
- Keywords
- Phaseolus vulgaris L., Glycemic Index, Food Insulin Index, Appetite, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jomo Kenyatta University of Agriculture and TechnologyUniversity, hospital or other
- Collaborators
- KU Leuven, Legumes Centre of Excellence for Food and Nutrition Security, VLIR-UOS
- Study start
- 4 Feb 2021 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers (Glycemic Index) | – | Dietary Supplement: Common bean productThe 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. |
| Healthy Volunteers(Food Insulin Index) | – | Dietary Supplement: Common bean productThe 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. |
| Type-2 diabetes (T2DM) patients | – | Dietary Supplement: Common bean productGlycemic, 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Healthy volunteers (incl. criteria)
- T2DM patients (incl. criteria)
Key exclusion criteria (11 listed)
- Healthy volunteers (excl. criteria)
- T2DM patients (excl. criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common bean productHealthy 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 | Dietary supplement | Healthy Volunteers (Glycemic Index), Healthy Volunteers(Food Insulin Index), Type-2 diabetes (T2DM) patients |
Primary outcome
Glycemic response
Time frame: 120 min
The effect associated with consumption of the common bean product on blood sugar (glucose) levels.
Insulinemic response
Time frame: 120 min
The effect associated with consumption of the common bean product on insulin levels.
Satiety
Time frame: 120 min
Appetite score refers to the average between hunger, desire to eat, prospective consumption and a 100-fullness score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- BackgroundISO, "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].
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Jomo Kenyatta University of Agriculture and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic response (time frame: 120 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04733690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.