PrediabetesAEGISNCT02260895
Almond Effects on Glucose Intolerance Study
A study testing Almond pre-test snack in people with Prediabetes, run by Memorial Hermann Health System at 1 site in United States.
Trial summary
Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an important goal. The progression from impaired glucose tolerance to diabetes is thought to be promoted by the toxic effects of hyperglycemia on pancreatic beta cells. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Almond pre-test snack
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of abnormal 1-hour OGTT result (>160 mg/dL) or 2-hour OGTT (>140)
Who cannot join
- History of a diagnosis of diabetes
- History of a 2-hour OGTT result >200 mg/dL
- History of a fasting glucose >125 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Physicians at Sugar Creek - Memorial Family Medicine Residency Program
Sugar Land, Texas, 77478
About this study
Official title: Almond Effects on Glucose Intolerance Study (AEGIS)
Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an important goal. The progression from impaired glucose tolerance to diabetes is thought to be promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is reduced first phase (immediate) insulin release. The investigators hypothesis is that consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.
The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).
The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40 mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to show a statistically significant difference between the almond pre-test snack and control standard OGTT conditions.
Read the detailed description
The study will be conducted at Physicians at Sugar Creek (PSC)-the model family practice center for the Memorial Family Medicine Residency Program. The ethnicity of PSC patients is approximately 30% non-Hispanic white, 30% Hispanic, 30% African-American, and 10% Asian.
Potential participants will be identified by searching PSC electronic medical records (Centricity) to find adults aged 18-75 with impaired glucose tolerance, without diabetes (one-hour oral glucose tolerance test result >160 md/dl and two-hour OGTT result <200 mg/dl), without hypoglycemic medications and corticosteroids on their active medications list, and without almond allergy on their allergy list.
Recruitment flyers will be posted in the clinic to encourage interested individuals to contact the investigators about their potential study eligibility. The investigators will also approach previously identified potentially eligible patients during routine clinical visits in the clinic, to elicit their interest in participating in the study. Those expressing interest will be scheduled for an intake visit with an investigator, to further ascertain their eligibility and invite eligible individuals to take part in the study. Interested eligible individuals who render verbal and written informed consent will then be instructed in the study protocol and scheduled for their first data gathering visit.
Each participant will be scheduled to undergo two 2-hour oral glucose tolerance tests (OGTT), starting between 7:00 and 9:30 a.m., one to four weeks apart. Test A will be a standard 75-gram OGTT. Test B will be an OGTT that will begin 30 minutes after ingestion of a low-carbohydrate pre-load "snack" consisting of 1/2 oz (14 grams) of unsalted, dry-roasted almonds (12 average size almonds). Each participant will be given an 8-ounce glass of water to drink with the almonds. Participants will be randomized to one of two test sequences (A-B or B-A), to control for sequence effects on results.
To minimize variability of OGTT results, participants will be asked to eat as they usually do throughout the study. Participants will be asked to refrain from vigorous physical activity for 8 hours prior to each OGTT and to minimize their physical activity during each OGTT. Participants will complete a Perceived Stress Scale and a 24-hour food, alcohol, and activity recall for the day before each OGTT to analyze potential confounding effects of stress, diet, alcohol, and physical activity on the results.
Blood sampling will be done for serial measurements of plasma glucose at time-zero, and at 60-minute intervals for two hours after each 75-gram glucose load. An investigator will monitor the timing of each blood draw closely to ensure timeliness. Blood will be drawn by one of two phlebotomists in the on-site laboratory and sent to the Memorial Hermann Southwest Hospital or Quest Lab (the latter only for the control OGTT, for patients whose insurance requires this) for analysis. The glucose results will be reported electronically to the patient's medical record in the routine manner for blood test results.
Investigators will abstract the glucose results from the patients' electronic medical records for data analysis purposes. The primary dependent variable is the mean difference in plasma glucose (fasting to 1-hr post 75-g glucose challenge, with vs. without snack. The secondary dependent variable is the mean difference in plasma glucose (fasting to 2-hr post 75-g glucose challenge, with vs. without snack). Student's t test will be used to analyze the differences between the standard 75-g OGTT results and the OGTT results following the almond pre-test snack. Analysis of variance will be used to analyze the data for confounding effects of ethnicity, gender, body mass index (BMI), and pre-test food and alcohol intake, physical activity, and perceived stress level.
Patients will receive their individual results and an investigator-generated evaluative commentary in a routine "lab letter". The results letter will be forwarded to each patient's primary care provider for review and appropriate clinical follow-up. Patients' results will be communicated scientifically in an aggregate manner, with no individual identifying information, to maintain patient confidentiality.
- Conditions
- Prediabetes
- Being tested
- Almond pre-test snack
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond pre-test snackDietary supplement
Also called unsalted, dry-roasted almonds
unsalted, dry-roasted almonds, 1/2 oz (14 g), ingested 30 minutes prior to the start of a two-hour oral glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard 2-hour 75-gram oral glucose tolerance test |
| Almond Pre-test snack | Experimental | 1/2 ounce (14 g) almond snack 30 minutes prior to a 2-hour 75-gram oral glucose tolerance test Receives: Dietary Supplement: Almond pre-test snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-hour OGTT result
One-hour oral glucose tolerance test result
Measured: 60 minutes into 2-hour oral glucose tolerance test
Secondary outcomes (1)
Two-hour OGTT result
Two-hour oral glucose tolerance test result (at 2 hours)
Measured: 120 minutes into 2-hour oral glucose tolerance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: The Investigator left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Hermann Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aryn Knight, Memorial Hermann Health System
- Investigators
- Michael A Crouch, MD, MSPH, Principal investigator, Memorial Hermann Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260895
- Sponsor's protocol ID
- HSC-MH-14-0667
- Acronym
- AEGIS
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2014
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almond Effects on Glucose Intolerance Study (AEGIS)
- ClinicalTrials.gov ID
- NCT02260895
- Acronym / sponsor ID
- AEGIS / HSC-MH-14-0667
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Investigator left the institution.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Memorial Hermann Health SystemUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Oct 2014 (estimated)
- 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.
Diabetes is a major cause of morbidity and mortality worldwide. Prevention of diabetes is an important goal. The progression from impaired glucose tolerance to diabetes is thought to be promoted by the toxic effects of hyperglycemia on pancreatic beta cells. One of the main defects causing postprandial hyperglycemia in individuals with impaired glucose tolerance is reduced first phase (immediate) insulin release. The investigators hypothesis is that consuming a nutritional preload--a low-calorie, nutritionally balanced snack--30 minutes before ingesting a carbohydrate load, will moderate the hyperglycemic response to subsequent carbohydrate challenge and reduce glucotoxicity by stimulating insulin release and synthesis.
The aim of this study is to test this hypothesis by comparing the standard 75-gram, two-hour oral glucose tolerance test (OGTT) response of 30 fasting adults who have impaired glucose tolerance to their OGTT response when the test is preceded by ½ ounce (14 grams) of dry-roasted, unsalted almonds. A pre-load interval of 30 minutes was chosen so that the peak of phase 2 (delayed) insulin response to the pre-load (45-60 minutes) would coincide with the timeframe of the steepest OGTT rise in glucose (15 to 30 minutes post challenge).
The investigators hypothesize that the one-hour OGTT glucose level will be approximately 40 mg/dl lower when participants consume the pre-OGTT almond snack, compared to their one-hour glucose level on the standard two-hour OGTT. The two-hour OGTT glucose level is unlikely to show a statistically significant difference between the almond pre-test snack and control standard OGTT conditions.
Detailed description
The study will be conducted at Physicians at Sugar Creek (PSC)-the model family practice center for the Memorial Family Medicine Residency Program. The ethnicity of PSC patients is approximately 30% non-Hispanic white, 30% Hispanic, 30% African-American, and 10% Asian.
Potential participants will be identified by searching PSC electronic medical records (Centricity) to find adults aged 18-75 with impaired glucose tolerance, without diabetes (one-hour oral glucose tolerance test result >160 md/dl and two-hour OGTT result <200 mg/dl), without hypoglycemic medications and corticosteroids on their active medications list, and without almond allergy on their allergy list.
Recruitment flyers will be posted in the clinic to encourage interested individuals to contact the investigators about their potential study eligibility. The investigators will also approach previously identified potentially eligible patients during routine clinical visits in the clinic, to elicit their interest in participating in the study. Those expressing interest will be scheduled for an intake visit with an investigator, to further ascertain their eligibility and invite eligible individuals to take part in the study. Interested eligible individuals who render verbal and written informed consent will then be instructed in the study protocol and scheduled for their first data gathering visit.
Each participant will be scheduled to undergo two 2-hour oral glucose tolerance tests (OGTT), starting between 7:00 and 9:30 a.m., one to four weeks apart. Test A will be a standard 75-gram OGTT. Test B will be an OGTT that will begin 30 minutes after ingestion of a low-carbohydrate pre-load "snack" consisting of 1/2 oz (14 grams) of unsalted, dry-roasted almonds (12 average size almonds). Each participant will be given an 8-ounce glass of water to drink with the almonds. Participants will be randomized to one of two test sequences (A-B or B-A), to control for sequence effects on results.
To minimize variability of OGTT results, participants will be asked to eat as they usually do throughout the study. Participants will be asked to refrain from vigorous physical activity for 8 hours prior to each OGTT and to minimize their physical activity during each OGTT. Participants will complete a Perceived Stress Scale and a 24-hour food, alcohol, and activity recall for the day before each OGTT to analyze potential confounding effects of stress, diet, alcohol, and physical activity on the results.
Blood sampling will be done for serial measurements of plasma glucose at time-zero, and at 60-minute intervals for two hours after each 75-gram glucose load. An investigator will monitor the timing of each blood draw closely to ensure timeliness. Blood will be drawn by one of two phlebotomists in the on-site laboratory and sent to the Memorial Hermann Southwest Hospital or Quest Lab (the latter only for the control OGTT, for patients whose insurance requires this) for analysis. The glucose results will be reported electronically to the patient's medical record in the routine manner for blood test results.
Investigators will abstract the glucose results from the patients' electronic medical records for data analysis purposes. The primary dependent variable is the mean difference in plasma glucose (fasting to 1-hr post 75-g glucose challenge, with vs. without snack. The secondary dependent variable is the mean difference in plasma glucose (fasting to 2-hr post 75-g glucose challenge, with vs. without snack). Student's t test will be used to analyze the differences between the standard 75-g OGTT results and the OGTT results following the almond pre-test snack. Analysis of variance will be used to analyze the data for confounding effects of ethnicity, gender, body mass index (BMI), and pre-test food and alcohol intake, physical activity, and perceived stress level.
Patients will receive their individual results and an investigator-generated evaluative commentary in a routine "lab letter". The results letter will be forwarded to each patient's primary care provider for review and appropriate clinical follow-up. Patients' results will be communicated scientifically in an aggregate manner, with no individual identifying information, to maintain patient confidentiality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard 2-hour 75-gram oral glucose tolerance test |
| Almond Pre-test snack | Experimental | Dietary Supplement: Almond pre-test snack1/2 ounce (14 g) almond snack 30 minutes prior to a 2-hour 75-gram oral glucose tolerance test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of abnormal 1-hour OGTT result (>160 mg/dL) or 2-hour OGTT (>140)
Key exclusion criteria (3 listed)
- History of a diagnosis of diabetes
- History of a 2-hour OGTT result >200 mg/dL
- History of a fasting glucose >125 mg/dL
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 |
|---|---|---|
| Almond pre-test snackAlso: unsalted, dry-roasted almondsunsalted, dry-roasted almonds, 1/2 oz (14 g), ingested 30 minutes prior to the start of a two-hour oral glucose tolerance test | Dietary supplement | Almond Pre-test snack |
Primary outcome
One-hour OGTT result
Time frame: 60 minutes into 2-hour oral glucose tolerance test
One-hour oral glucose tolerance test result
1 secondary outcome
Two-hour OGTT result
Time frame: 120 minutes into 2-hour oral glucose tolerance test
Results and safety
The study was stopped early (reason given: The Investigator left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
Michael A Crouch, MD, MSPH principal investigator
Memorial Hermann Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond pre-test snack in people with Prediabetes, run by Memorial Hermann Health System 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 1 inclusion and 3 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 20 Mar 2024. 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: The Investigator left the institution.). 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?
One-hour OGTT result (time frame: 60 minutes into 2-hour oral glucose tolerance test). 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 20 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.