Diabetes MellitusNCT04171648
Effect of Dry Roasted Peanuts and Boiled Peanuts on Glycemic Control
A study testing Roasted Peanut Treatment and Boiled Peanut Treatment in people with Diabetes Mellitus and Glycemic Control, run by North Carolina State University at 1 site in United States.
Trial summary
Research on glycemic control related to nuts or whole snack foods has focused primarily on tree nuts. Different processing and cooking methods have not been comprehensively analyzed to observe the effect on nutrient quality, bioavailability, or digestive absorption in peanuts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Glycemic Control
- What is being tested?
- Roasted Peanut Treatment and Boiled Peanut Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 18 Mar 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women with ages 18 to 65
- BMI ranges [(in kg/m2) 18.5>24.9] from Raleigh-Durham area 3. We will not recruit pregnant women
Who cannot join
- BMI >24.9 kg/m2 or <18 kg/m2
- Type 1 or 2 diabetes
- Anemia
- Fasting glucose >125 mg/dL
- Use of medication that affect glucose metabolism, renal, liver, pancreatic, or cardiovascular disease.
- Uncontrolled hypertension
Show all 14Show fewer
- Disorders of the esophageal or in gastrointestinal motility
- Hypo- or hyperthyroidism
- Allergy to peanuts
- Pregnancy.
- Body weight < 110 lb
- Insulin Resistance
- Polycystic Ovary Syndrome
- Food intolerances
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina State University
Raleigh, North Carolina, 27607
About this study
Research on glycemic control related to nuts or whole snack foods has focused primarily on tree nuts. Different processing and cooking methods have not been comprehensively analyzed to observe the effect on nutrient quality, bioavailability, or digestive absorption in peanuts. There is little to no research surrounding the nutrition of boiled peanuts so it may be of interest to compare boiled to roasted peanuts in terms of glycemic control. Peanuts have been shown to have a similar beneficial effect on glycemic control while being more financially accessible than almonds. Glycemic control could be improved based on the low glycemic index, high fiber, lipid, and or protein content of peanuts. The acute trial (phase 1) will investigate the impact of preprandial peanut consumption on glycemic response. The participants will complete an oral glucose tolerance test for both roasted and boiled peanuts. The long term study (phase 2\&3) consists of participants consuming one serving per day of boiled or roasted peanuts in a four week crossover trial to observe any long term impact of daily peanut snacking on glycemic control. (Wash out weeks occurring between all trials.) At the conclusion of phase 2 \& 3 an oral glucose tolerance test will be executed. The subjects will self record a exercise/step count and diet dairy, weight and waist to hip ratio will be measured weekly. The study will aim for a male and/or female healthy population from 18-65 years of age at NCSU.
Read the detailed description
Participants will be recruited via flyers, oral presentations, and emails. The recruitment methods will briefly describe the study, eligibility, and compensation asking potential subjects to contact Brooke Wilson for more information (by email) in which Brooke will respond by email with the time and place of the informational meeting that will include the screening process of the health screening questionnaire. The questionnaire will be attached/included in the response email so the interested individual may see if they are eligible before coming to the meeting. The health screen questionnaire will not be kept by the research team, if the participant says "yes" to any question they are determined to be not eligible and investigators will shred all health questionnaires and no participant needs to write their name on a questionnaire. At the informational meeting the study protocol, schedule of phases including total hours required, risks and benefits, and compensation will be discussed as well as physical copy of the consent form will be given to review. A health screening questionnaire will be provided and the subject will fill it out privately and/or ask questions if required. Those individuals who meet the initial eligibility criteria included in the questionnaire and voluntarily signs the consent form will be asked to schedule an oral glucose tolerance test as a following separate meeting that will determine if their glycemic response meets the final eligibility. Oral Glucose Tolerance Test ELIGIBILITY: (1 morning duration ~3 hours in lab) The investigators will inform participants at the meeting (also described in consent form) that the test will start early in the morning when they have not eaten anything since the previous evening, or at least 6 to 8 hours in this fasted state. The screening will measure fasting blood glucose (one reading of blood glucose before the test begins) and a glucose tolerance test will be done to rule out subjects with insulin resistance. A glucose tolerance test measures changes in blood glucose over a 2-hr period after consuming a glucose drink containing 50 g of glucose. Blood samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90, 105, and 120 min after consuming the treatments using a glucometer to take capillary blood samples (finger-pricks); (The "oral" descriptor of the test refers to the fact that the individual orally ingests a 50 gram glucose drink which mimics a standard meals spike in the blood glucose response. The "oral" differentiates the method of administering glucose, such as in other cases the glucose can be injected intravenously instead of ingested through food or drink form. All glucose tolerance tests will monitor blood glucose by using continuous glucometers or drawing blood in increments of time.) No participant will be left alone during the oral glucose tolerance test, during all tests Brooke Wilson and a second research team member will be with the participants. Brooke Wilson and staff will measure height, hip to waist ratio and weight of the subjects. These measurements will be taken in a private room, with two staff at all time that are the same gender as the participant, and everyone will be fully clothed during all times. Professors will not take any measurements. Height and weight are measured to calculate body mass index over the course of the study to observe any weight changes that may be associated with a change in diet. Measuring hip to waist ratio will give a more accurate idea of weight distribution, general health, and risk of certain diseases. Subjects with glucose responses considered normal/healthy will be invited to continue in the study. It is possible that a participant could pass the health screen questionnaire, sign the consent form, and then fail the oral glucose tolerance test in which they will not be allowed to continue in the study and will not be compensated in any form. The consent form must be signed before the oral glucose tolerance test to determine eligibility for the participants safety and awareness of risks. The oral glucose tolerance test conducted for eligibility will also function as a baseline reading for those participants who complete the study. The health screening questionnaire will be shredded immediately after the subjects agree to participate or are disqualified from the study. (If disqualified the oral glucose tolerance test data will be destroyed as well.) This study consists of three parts. The first being phase 1, the second being phase 2, and the third being phase 3. The phase 1 data will stand on its own in the reporting of this study. The long term study is separated into two parts (phase 2 and phase 3) because it is a cross over study, meaning in phase 2 participants will be given either roasted or boiled peanuts (by random assignment) to consume daily for two weeks, then a wash out week will separate phase 2 and 3, and then phase 3 (by the same protocol as phase 2) with the same participants EXCEPT the food treatments will be switched (those who ate roasted peanuts in phase 2 will eat boiled peanuts in phase 3 and vice versa). The data from phase 2 and 3 will be reported together as the experimental design requires each participants to do both treatments. In terms of a time line the phases will be conducted in this order: (Screening and Eligibility - includes 1 oral glucose tolerance test) 1.Phase 1 (includes 2 oral glucose tolerance tests) 2.Wash out week 3.Phase 2 (includes 1 oral glucose tolerance test) 4. Wash out week 5.Phase 3 (includes 1 oral glucose tolerance test) PHASE 1: (2 morning duration in 1 week ~6 hours in lab) Participants will complete an oral glucose tolerance test (OGTT) for the boiled peanut, and roasted peanut treatment (the eligibility oral glucose tolerance test will serve as the control group for phase 1). In the duration of one week the participants will come in on a Wednesday morning for the boiled peanut OGTT and a Friday morning to complete the roasted peanut OGTT. Both OGTT sessions will be conducted as followed: The participants must be fasted when arriving at the lab, meaning they have not eaten in the last 6-8 hours for the scheduled test early in the morning. The participant will consume their treatment food 0 to 15 minutes before consuming the 50g glucose drink. Once the 50 g glucose drink (must be consumed within 10 minuted) is consumed the OGTT will be conducted the same as the eligibility OGTT. The change in blood glucose will be measured over a 2-hr period immediately after consuming the treatment food and 50g glucose drink, blood samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90,120 min using a glucometer to take capillary blood samples (finger-pricks); Investigators will measure height, hip to waist ratio and weight. WASH OUT WEEK: (1 week duration) The participants will return to a free living protocol and will not consume any phase samples (roasted or boiled peanuts) between the phase 1, phase 2 and phase 3. (Participants will be instructed to record all data (exercise/steps and diet) on a paper data collection sheet/diary supplied throughout all phases. At the conclusion of the study during the last glucose tolerance test the participants will hand in their food/exercise diary to Brooke Wilson, the diaries will be immediately transported by her on foot to room 221 of Schaub Hall, locked in a drawer of the graduate office (only Brooke Wilson has the key to the drawer) in which the door to enter the office is locked by a card reader only accessed by associated staff. Investigators will provide a pedometer to participants if they do not have one so they can measure daily activity as a step count. Refer to "19049 information sheet for participant" supporting document for the instructions given to participants on how to use the glucometer, the pedometer, and food restrictions required.) PHASE 2: (2 week duration) Participants will be randomized into the boiled peanut or roasted peanut treatment group. When the participants return to the lab, they will be given the two weeks worth of samples (14 portions of 48 gram servings) for phase 2 (premeasured and separated into individual containers) that they will consume once daily. Depending on the phase, roasted or boiled, they will be instructed on how to properly store the food items to discourage foodborne illness. They will be instructed to consume the sample around the same time everyday between lunch and dinner, to consume in one sitting of 30 minutes instead of throughout the day, and to record the actual time the sample is consumed. PHASE 2 ORAL GLUCOSE TOLERANCE TEST: (1 morning duration ~3 hours in lab) Once the subjects have completed the two weeks of daily x peanut consumption they will complete a oral glucose tolerance test. The participants must be fasted when arrived at the lab, meaning they have not eaten in the last 6-8 hours for the scheduled test early in the morning. The change in blood glucose will be measured over a 2-hr period immediately after consuming a 50g glucose drink. Blood samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90,120 min after consuming the drink using a glucometer to take capillary blood samples (finger-pricks); Investigators will measure height, hip to waist ratio and weight. WASH OUT WEEK: (1 week duration) The participants will return to a completely free living protocol and will not consume any phase samples between phase 2 and phase 3. PHASE 3: (2 week duration) The same procedure for the phase 2 will be used for phase 3 except the groups will switch respective phase samples. PHASE 3 ORAL GLUCOSE TOLERANCE TEST:(1 morning duration ~3 hours in lab) The same procedure for the phase 2 oral glucose tolerance test will be used for phase 3. Investigators will measure height, hip to waist ratio and weight. Throughout the entire procedure the participants may live their life as they normally would except for the following rules. They are strongly discouraged from drinking whatsoever (especially more than 2 drinks per day and or drinking more than 4 drinks in two hours during any time of the study). Also the participants should not do any non habitual exercise less than 10 hours before any oral glucose tolerance test. A phlebotomist is not necessary as the lancing of fingers to obtain enough blood for the glucometer is a common practice and instrument is sold over the counter. As well the glucometer only requires about 50 microliters per finger stick or less, each participant will be required to do five oral glucose tolerance tests including 10 finger lances per test. So in total the greatest amount of blood each participant will draw is 2,500 microliters or the equivalent of 2.5 milliliters. The instruction below of how to properly use a glucose monitor, including lancing of the finger, has been sourced from the Centers for Disease Control and Prevention: -Make sure the glucometer is clean and ready to use, turn on the glucometer. -Wash hands with soap and warm water. Dry well. Massage the hands to get blood into the finger. -Remove the cap off the lancet device, insert lancet until a click is heard to ensure it is secure, twist off the protective top to the lancet exposing the needle and cap the lancet device. -After removing a test strip, immediately close the test strip container tightly. Test strips can be damaged if they are exposed to moisture. -Insert the test strip into the glucometer; check to make sure the glucometer is on. - Place the lancet against the side of the preferred finger; press the button to lance the finger. Prick the finger on the side rather than the tip or pad of finger for less pain. Squeezing from the base of the finger (if it requires a lot of force or no blood is coming out stop and lance again in a different location), gently place a small amount of blood onto the test strip. -After a few seconds, the reading will appear. Track and record the results. -Properly dispose the lancet by removing the lancet device top, recapping the lancet itself and pull the capped lancet out of the device and throw it away. Remove test strip from glucometer and put in appropriate trash container. https://www.cdc.gov/diabetes/managing/managing-blood-sugar/bloodglucosemonitoring.html Pedometer information: PedUSA CW Step Pedometer The pedometer provided only records the amount of steps taken between clearing of data (a button to reset the step count each day). The pedometer does not track any other data than a step count. The participants are allowed to provide their own step counter, in the form of a Fitbit, smart watch, Garmin etc, as long as the device used for the participant is consistent throughout the study. Any step counter apps (not provided) have separate terms of service that may indicate that the users information is shared with third parties that are not the research team, and the information is not confidential. The research team is not responsible for any data shared through these apps as the use of these apps and the awareness and agreement of their terms of use are at the discretion of the participant. *Please refer to the document "MyFitnessPal and Alternative Step Counter Use: Information Related to Personal Data Confidentiality" provided to all participants discussing the data/personal information confidentiality using these technology. * In all situations the participants must physically write down or record their steps in their food diary/exercise diary to be collected by us at the end of each phase. If the pedometer is lost or broken the subject will be provided with a replacement. 50 gram glucose drink information: Azer Scientific Glucose Tolerance Beverages, manufacture # Azer Scientific 10O050, catalog # 22-026-203. The beverage is in compliance with Food and Drug Administration, World Health Organization, and American Diabetes Association. It comes in a premeasured factory sealed bottle ready for consumption and stored at room temperature. Through the course of this study, the participant will spend 15 hours at a lab testing blood glucose levels (in 3-hour sessions) plus 10 minutes per day tracking food and exercise. The total amount of time the participants will spend in this study is 21 hours.
- Conditions
- Diabetes Mellitus, Glycemic Control
- Being tested
- Roasted Peanut Treatment, Boiled Peanut Treatment
- Keywords
- diet management, weight management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roasted Peanut TreatmentOther
The subjects will consume 2 ounces or ~48 grams of roasted in shell peanuts a day for two weeks.
Boiled Peanut TreatmentOther
The subjects will consume 2 ounces or ~48 grams of boiled peanuts a day for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Roasted Peanut Group 1 | Experimental | Arm 1 is the arm of participants that will receive the roasted peanut treatment first and then will crossover to the boiled peanut treatment. Receives: Other: Roasted Peanut Treatment; Other: Boiled Peanut Treatment |
| Boiled Peanut Group 1 | Experimental | Arm 2 is the arm of participants that will receive the boiled peanut treatment first then will crossover to the roasted peanut treatment. Receives: Other: Roasted Peanut Treatment; Other: Boiled Peanut Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Blood Glucose Response (Glycemic Response)
The blood glucose response will be measured during each oral glucose tolerance test. These tests will happen periodically through out the study to determine if there is any correlation and or significant difference in glycemic response between consuming boiled or roasted peanuts (acute and chronic consumption). The metric is the blood glucose concentration measured by a blood glucose monitor by finger prick 10 times over a two hour period after consuming a standardized 50 gram glucose beverage. The 10 blood glucose measurements are synthesized into one measurement to display a pattern of blood glucose concentrations called the glycemic response.
Please refer to Study Description -Detailed Description for a more thorough explanation.
Measured: [week 1 - phase 1 - three measurements mon/wed/fri] [week 2 - wash out week] [week 3 & week 4- phase 2 - one measurement at the end of week 4] [week 5 - wash out week] [week 6 & week 7 - phase 3 - one measurement at end of week 7]
Secondary outcomes (2)
weight change
Weight of each participant will be measured to determine any weight loss or gain during the study.
Measured: Once week one, once week 4, once week 8.
waist to hip ratio
Waist to hip ration of each participant will be measured to further define any weight change during the study.
Measured: Once week one, once week 4, once week 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start2 Mar 2020
- Primary completion17 Mar 2020
- Study completion18 Mar 2020
Why it stopped: Covid-19 Pandemic halted my study due to exposure risks.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Half the subjects will receive the roasted peanut treatment and the other half will receive the boiled peanut treatment for two weeks, then both will have a week wash out, and then each group will switch to the opposite treatment for two weeks.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brooke Wilson, North Carolina State University
- Investigators
- Jonathan C Allen, PhD, Study chair, North Carolina State UniversityLisa Dean, PhD, Study director, USDA ARS - Market Quality and Handling Unit, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171648
- Sponsor's protocol ID
- 19049
- Status last verified
- Sep 2020
- First submitted
- 15 Nov 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The de-identified individual participant data will not be shared unless the study is successful and is published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dry Roasted Peanuts and Boiled Peanuts on Glycemic Control
- ClinicalTrials.gov ID
- NCT04171648
- Acronym / sponsor ID
- 19049
- Conditions
- Diabetes Mellitus, Glycemic Control
- Keywords
- diet management, weight management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 Pandemic halted my study due to exposure risks.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 21 Nov 2019 (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.
Research on glycemic control related to nuts or whole snack foods has focused primarily on tree nuts. Different processing and cooking methods have not been comprehensively analyzed to observe the effect on nutrient quality, bioavailability, or digestive absorption in peanuts. There is little to no research surrounding the nutrition of boiled peanuts so it may be of interest to compare boiled to roasted peanuts in terms of glycemic control. Peanuts have been shown to have a similar beneficial effect on glycemic control while being more financially accessible than almonds. Glycemic control could be improved based on the low glycemic index, high fiber, lipid, and or protein content of peanuts. The acute trial (phase 1) will investigate the impact of preprandial peanut consumption on glycemic response. The participants will complete an oral glucose tolerance test for both roasted and boiled peanuts. The long term study (phase 2\&3) consists of participants consuming one serving per day of boiled or roasted peanuts in a four week crossover trial to observe any long term impact of daily peanut snacking on glycemic control. (Wash out weeks occurring between all trials.) At the conclusion of phase 2 \& 3 an oral glucose tolerance test will be executed. The subjects will self record a exercise/step count and diet dairy, weight and waist to hip ratio will be measured weekly. The study will aim for a male and/or female healthy population from 18-65 years of age at NCSU.
Detailed description
Participants will be recruited via flyers, oral presentations, and emails. The recruitment methods will briefly describe the study, eligibility, and compensation asking potential subjects to contact Brooke Wilson for more information (by email) in which Brooke will respond by email with the time and place of the informational meeting that will include the screening process of the health screening questionnaire. The questionnaire will be attached/included in the response email so the interested individual may see if they are eligible before coming to the meeting. The health screen questionnaire will not be kept by the research team, if the participant says "yes" to any question they are determined to be not eligible and investigators will shred all health questionnaires and no participant needs to write their name on a questionnaire. At the informational meeting the study protocol, schedule of phases including total hours required, risks and benefits, and compensation will be discussed as well as physical copy of the consent form will be given to review. A health screening questionnaire will be provided and the subject will fill it out privately and/or ask questions if required. Those individuals who meet the initial eligibility criteria included in the questionnaire and voluntarily signs the consent form will be asked to schedule an oral glucose tolerance test as a following separate meeting that will determine if their glycemic response meets the final eligibility. Oral Glucose Tolerance Test ELIGIBILITY: (1 morning duration ~3 hours in lab) The investigators will inform participants at the meeting (also described in consent form) that the test will start early in the morning when they have not eaten anything since the previous evening, or at least 6 to 8 hours in this fasted state. The screening will measure fasting blood glucose (one reading of blood glucose before the test begins) and a glucose tolerance test will be done to rule out subjects with insulin resistance. A glucose tolerance test measures changes in blood glucose over a 2-hr period after consuming a glucose drink containing 50 g of glucose. Blood samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90, 105, and 120 min after consuming the treatments using a glucometer to take capillary blood samples (finger-pricks); (The "oral" descriptor of the test refers to the fact that the individual orally ingests a 50 gram glucose drink which mimics a standard meals spike in the blood glucose response. The "oral" differentiates the method of administering glucose, such as in other cases the glucose can be injected intravenously instead of ingested through food or drink form. All glucose tolerance tests will monitor blood glucose by using continuous glucometers or drawing blood in increments of time.) No participant will be left alone during the oral glucose tolerance test, during all tests Brooke Wilson and a second research team member will be with the participants. Brooke Wilson and staff will measure height, hip to waist ratio and weight of the subjects. These measurements will be taken in a private room, with two staff at all time that are the same gender as the participant, and everyone will be fully clothed during all times. Professors will not take any measurements. Height and weight are measured to calculate body mass index over the course of the study to observe any weight changes that may be associated with a change in diet. Measuring hip to waist ratio will give a more accurate idea of weight distribution, general health, and risk of certain diseases. Subjects with glucose responses considered normal/healthy will be invited to continue in the study. It is possible that a participant could pass the health screen questionnaire, sign the consent form, and then fail the oral glucose tolerance test in which they will not be allowed to continue in the study and will not be compensated in any form. The consent form must be signed before the oral glucose tolerance test to determine eligibility for the participants safety and awareness of risks. The oral glucose tolerance test conducted for eligibility will also function as a baseline reading for those participants who complete the study. The health screening questionnaire will be shredded immediately after the subjects agree to participate or are disqualified from the study. (If disqualified the oral glucose tolerance test data will be destroyed as well.) This study consists of three parts. The first being phase 1, the second being phase 2, and the third being phase 3. The phase 1 data will stand on its own in the reporting of this study. The long term study is separated into two parts (phase 2 and phase 3) because it is a cross over study, meaning in phase 2 participants will be given either roasted or boiled peanuts (by random assignment) to consume daily for two weeks, then a wash out week will separate phase 2 and 3, and then phase 3 (by the same protocol as phase 2) with the same participants EXCEPT the food treatments will be switched (those who ate roasted peanuts in phase 2 will eat boiled peanuts in phase 3 and vice versa). The data from phase 2 and 3 will be reported together as the experimental design requires each participants to do both treatments. In terms of a time line the phases will be conducted in this order: (Screening and Eligibility - includes 1 oral glucose tolerance test) 1.Phase 1 (includes 2 oral glucose tolerance tests) 2.Wash out week 3.Phase 2 (includes 1 oral glucose tolerance test) 4. Wash out week 5.Phase 3 (includes 1 oral glucose tolerance test) PHASE 1: (2 morning duration in 1 week ~6 hours in lab) Participants will complete an oral glucose tolerance test (OGTT) for the boiled peanut, and roasted peanut treatment (the eligibility oral glucose tolerance test will serve as the control group for phase 1). In the duration of one week the participants will come in on a Wednesday morning for the boiled peanut OGTT and a Friday morning to complete the roasted peanut OGTT. Both OGTT sessions will be conducted as followed: The participants must be fasted when arriving at the lab, meaning they have not eaten in the last 6-8 hours for the scheduled test early in the morning. The participant will consume their treatment food 0 to 15 minutes before consuming the 50g glucose drink. Once the 50 g glucose drink (must be consumed within 10 minuted) is consumed the OGTT will be conducted the same as the eligibility OGTT. The change in blood glucose will be measured over a 2-hr period immediately after consuming the treatment food and 50g glucose drink, blood samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90,120 min using a glucometer to take capillary blood samples (finger-pricks); Investigators will measure height, hip to waist ratio and weight. WASH OUT WEEK: (1 week duration) The participants will return to a free living protocol and will not consume any phase samples (roasted or boiled peanuts) between the phase 1, phase 2 and phase 3. (Participants will be instructed to record all data (exercise/steps and diet) on a paper data collection sheet/diary supplied throughout all phases. At the conclusion of the study during the last glucose tolerance test the participants will hand in their food/exercise diary to Brooke Wilson, the diaries will be immediately transported by her on foot to room 221 of Schaub Hall, locked in a drawer of the graduate office (only Brooke Wilson has the key to the drawer) in which the door to enter the office is locked by a card reader only accessed by associated staff. Investigators will provide a pedometer to participants if they do not have one so they can measure daily activity as a step count. Refer to "19049 information sheet for participant" supporting document for the instructions given to participants on how to use the glucometer, the pedometer, and food restrictions required.) PHASE 2: (2 week duration) Participants will be randomized into the boiled peanut or roasted peanut treatment group. When the participants return to the lab, they will be given the two weeks worth of samples (14 portions of 48 gram servings) for phase 2 (premeasured and separated into individual containers) that they will consume once daily. Depending on the phase, roasted or boiled, they will be instructed on how to properly store the food items to discourage foodborne illness. They will be instructed to consume the sample around the same time everyday between lunch and dinner, to consume in one sitting of 30 minutes instead of throughout the day, and to record the actual time the sample is consumed. PHASE 2 ORAL GLUCOSE TOLERANCE TEST: (1 morning duration ~3 hours in lab) Once the subjects have completed the two weeks of daily x peanut consumption they will complete a oral glucose tolerance test. The participants must be fasted when arrived at the lab, meaning they have not eaten in the last 6-8 hours for the scheduled test early in the morning. The change in blood glucose will be measured over a 2-hr period immediately after consuming a 50g glucose drink. Blood samples will be taken at 10, 20, 30, 40, 50, 60, 75, 90,120 min after consuming the drink using a glucometer to take capillary blood samples (finger-pricks); Investigators will measure height, hip to waist ratio and weight. WASH OUT WEEK: (1 week duration) The participants will return to a completely free living protocol and will not consume any phase samples between phase 2 and phase 3. PHASE 3: (2 week duration) The same procedure for the phase 2 will be used for phase 3 except the groups will switch respective phase samples. PHASE 3 ORAL GLUCOSE TOLERANCE TEST:(1 morning duration ~3 hours in lab) The same procedure for the phase 2 oral glucose tolerance test will be used for phase 3. Investigators will measure height, hip to waist ratio and weight. Throughout the entire procedure the participants may live their life as they normally would except for the following rules. They are strongly discouraged from drinking whatsoever (especially more than 2 drinks per day and or drinking more than 4 drinks in two hours during any time of the study). Also the participants should not do any non habitual exercise less than 10 hours before any oral glucose tolerance test. A phlebotomist is not necessary as the lancing of fingers to obtain enough blood for the glucometer is a common practice and instrument is sold over the counter. As well the glucometer only requires about 50 microliters per finger stick or less, each participant will be required to do five oral glucose tolerance tests including 10 finger lances per test. So in total the greatest amount of blood each participant will draw is 2,500 microliters or the equivalent of 2.5 milliliters. The instruction below of how to properly use a glucose monitor, including lancing of the finger, has been sourced from the Centers for Disease Control and Prevention: -Make sure the glucometer is clean and ready to use, turn on the glucometer. -Wash hands with soap and warm water. Dry well. Massage the hands to get blood into the finger. -Remove the cap off the lancet device, insert lancet until a click is heard to ensure it is secure, twist off the protective top to the lancet exposing the needle and cap the lancet device. -After removing a test strip, immediately close the test strip container tightly. Test strips can be damaged if they are exposed to moisture. -Insert the test strip into the glucometer; check to make sure the glucometer is on. - Place the lancet against the side of the preferred finger; press the button to lance the finger. Prick the finger on the side rather than the tip or pad of finger for less pain. Squeezing from the base of the finger (if it requires a lot of force or no blood is coming out stop and lance again in a different location), gently place a small amount of blood onto the test strip. -After a few seconds, the reading will appear. Track and record the results. -Properly dispose the lancet by removing the lancet device top, recapping the lancet itself and pull the capped lancet out of the device and throw it away. Remove test strip from glucometer and put in appropriate trash container. https://www.cdc.gov/diabetes/managing/managing-blood-sugar/bloodglucosemonitoring.html Pedometer information: PedUSA CW Step Pedometer The pedometer provided only records the amount of steps taken between clearing of data (a button to reset the step count each day). The pedometer does not track any other data than a step count. The participants are allowed to provide their own step counter, in the form of a Fitbit, smart watch, Garmin etc, as long as the device used for the participant is consistent throughout the study. Any step counter apps (not provided) have separate terms of service that may indicate that the users information is shared with third parties that are not the research team, and the information is not confidential. The research team is not responsible for any data shared through these apps as the use of these apps and the awareness and agreement of their terms of use are at the discretion of the participant. *Please refer to the document "MyFitnessPal and Alternative Step Counter Use: Information Related to Personal Data Confidentiality" provided to all participants discussing the data/personal information confidentiality using these technology. * In all situations the participants must physically write down or record their steps in their food diary/exercise diary to be collected by us at the end of each phase. If the pedometer is lost or broken the subject will be provided with a replacement. 50 gram glucose drink information: Azer Scientific Glucose Tolerance Beverages, manufacture # Azer Scientific 10O050, catalog # 22-026-203. The beverage is in compliance with Food and Drug Administration, World Health Organization, and American Diabetes Association. It comes in a premeasured factory sealed bottle ready for consumption and stored at room temperature. Through the course of this study, the participant will spend 15 hours at a lab testing blood glucose levels (in 3-hour sessions) plus 10 minutes per day tracking food and exercise. The total amount of time the participants will spend in this study is 21 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half the subjects will receive the roasted peanut treatment and the other half will receive the boiled peanut treatment for two weeks, then both will have a week wash out, and then each group will switch to the opposite treatment for two weeks.
| Arm | Type | Receives |
|---|---|---|
| Roasted Peanut Group 1 | Experimental | Other: Roasted Peanut Treatment, Other: Boiled Peanut TreatmentArm 1 is the arm of participants that will receive the roasted peanut treatment first and then will crossover to the boiled peanut treatment. |
| Boiled Peanut Group 1 | Experimental | Other: Roasted Peanut Treatment, Other: Boiled Peanut TreatmentArm 2 is the arm of participants that will receive the boiled peanut treatment first then will crossover to the roasted peanut treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women with ages 18 to 65
- BMI ranges [(in kg/m2) 18.5>24.9] from Raleigh-Durham area 3. We will not recruit pregnant women
Key exclusion criteria (14 listed)
- BMI >24.9 kg/m2 or <18 kg/m2
- Type 1 or 2 diabetes
- Anemia
- Fasting glucose >125 mg/dL
- Use of medication that affect glucose metabolism, renal, liver, pancreatic, or cardiovascular disease.
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 |
|---|---|---|
| Roasted Peanut TreatmentThe subjects will consume 2 ounces or ~48 grams of roasted in shell peanuts a day for two weeks. | Other | Boiled Peanut Group 1, Roasted Peanut Group 1 |
| Boiled Peanut TreatmentThe subjects will consume 2 ounces or ~48 grams of boiled peanuts a day for two weeks. | Other | Boiled Peanut Group 1, Roasted Peanut Group 1 |
Primary outcome
Change from Baseline Blood Glucose Response (Glycemic Response)
Time frame: [week 1 - phase 1 - three measurements mon/wed/fri] [week 2 - wash out week] [week 3 & week 4- phase 2 - one measurement at the end of week 4] [week 5 - wash out week] [week 6 & week 7 - phase 3 - one measurement at end of week 7]
The blood glucose response will be measured during each oral glucose tolerance test. These tests will happen periodically through out the study to determine if there is any correlation and or significant difference in glycemic response between consuming boiled or roasted peanuts (acute and chronic consumption). The metric is the blood glucose concentration measured by a blood glucose monitor by finger prick 10 times over a two hour period after consuming a standardized 50 gram glucose beverage. The 10 blood glucose measurements are synthesized into one measurement to display a pattern of blood glucose concentrations called the glycemic response. Please refer to Study Description -Detailed Description for a more thorough explanation.
2 secondary outcomes
weight change
Time frame: Once week one, once week 4, once week 8.
waist to hip ratio
Time frame: Once week one, once week 4, once week 7.
Results and safety
The study was stopped early (reason given: Covid-19 Pandemic halted my study due to exposure risks.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No. The de-identified individual participant data will not be shared unless the study is successful and is published.
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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.
Jonathan C Allen, PhD study chair
North Carolina State University
Lisa Dean, PhD study director
USDA ARS - Market Quality and Handling Unit, North Carolina State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roasted Peanut Treatment and Boiled Peanut Treatment in people with Diabetes Mellitus and Glycemic Control, run by North Carolina State University at 1 site in United States.
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 2 inclusion and 14 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: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Covid-19 Pandemic halted my study due to exposure risks.). 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?
Change from Baseline Blood Glucose Response (Glycemic Response) (time frame: [week 1 - phase 1 - three measurements mon/wed/fri] [week 2 - wash out week] [week 3 & week 4- phase 2 - one measurement at the end of week 4] [week 5 - wash out week] [week 6 & week 7 - phase 3 - one measurement at end of week 7]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2020.