PreDiabetesNCT03126981
Effects of Almonds on Insulin Sensitivity in Prediabetes
A study testing 1.5 oz of whole, natural almonds and Low-fat, high refined starches/sugars in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice daily on insulin sensitivity and markers of cardiometabolic health in men and women with prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- 1.5 oz of whole, natural almonds and Low-fat, high refined starches/sugars
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2017to 26 Sep 2018
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI of 25.0-39.9 kg/m2
- Prediabetic: fingerstick glycated hemoglobin 5.7-6.4% (inclusive), or fasting fingerstick capillary glucose of 100-125 mg/dL (inclusive), or 2-h post-prandial glucose of 140-199 mg/dL.
- Fasting LDL-C level <200 mg/dL and fasting TG level <400 mg/dL.
- Judged to be in general good health on the basis of medical history and screening laboratory tests.
Who cannot join
- Atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound], history of myocardial infarction, angina, a revascularization procedure, or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type I or type II diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study foods.
- Uncontrolled hypertension.
- Recent history of cancer, except for non-melanoma skin cancer.
- Recent change in body weight of ± 4.5 kg (9.9 lbs).
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- Recent use of any medications intended to alter the lipid profile (e.g. bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, and/or PCSK9 inhibitors, with the exception of the stable use of statins), weight-loss drugs or programs, systemic corticosteroid drugs, unstable use of any antihypertensive medication; medications known to influence CHO metabolism (e.g. adrenergic receptor blockers, diuretics, and/or hypoglycemic medications).
- Recent use of food/supplements known to influence lipid metabolism (e.g. omega-3 fatty acid supplements (e.g., flaxseed, fish or algal oils) or fortified foods, sterol/stanol products; dietary supplements (red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >400 mg/d, and irregular or inconsistent use of Metamucil® or viscous fiber-containing supplements.
- Recent use of antibiotics.
- Pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Extreme dietary habits (e.g. very low CHO diet, vegan, etc.).
- Current or recent history, or strong potential, for drug or alcohol abuse.
- History of a diagnosed eating disorder. -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MB Clinical Research
Boca Raton, Florida, 33487
Illinois Institute for Food Safety and Health (IFSH) at Illinois Instiute of Technology (IIT)
Chicago, Illinois, 60616
About this study
Official title: A Randomized, Crossover Trial to Assess the Effects of Replacing Refined Carbohydrates With Almonds on Insulin Sensitivity in Men and Women With Prediabetes.
The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice daily on insulin sensitivity and markers of cardiometabolic health in men and women with prediabetes.
Read the detailed description
This is a randomized, controlled, two-period crossover study that includes two screening visits, and two 6-week test periods, separated by a 4-week washout. Subjects consume twice daily, 1.5 oz whole, natural almonds (Active Condition) or low-fat foods high in refined starches and added sugars, matched for energy content to the almonds (Control Condition). The assigned study products will be dispensed with instructions to consume 2 servings (Active Product) or 3 servings (Control Products) each day, starting on day 1. Subjects will be screened for prediabetes at the first screening visits. An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period. Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein (hs-CRP) measurements at all visits. Additionally, blood will be drawn for measurement of Apolipoprotein B and A1, lipoprotein particles and subfractions, Interleukin 6 (IL-6) and Uric acid at the beginning and the end of each test period. Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, medication/supplement use, and adverse effects will be performed throughout the study. Compliance will be assessed through a daily log record, and return of unopened study product.
- Conditions
- PreDiabetes
- Being tested
- 1.5 oz of whole, natural almonds, Low-fat, high refined starches/sugars
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 oz of whole, natural almondsOther
1.5 oz of whole, natural almonds
Low-fat, high refined starches/sugarsOther
Low-fat foods, high in refined starches and added sugars
| Study group | Role | What they receive |
|---|---|---|
| Whole, natural almonds | Experimental | 1.5 oz of whole, natural almonds Receives: Other: 1.5 oz of whole, natural almonds |
| Low-fat, high refined starches/sugars | Placebo comparator | Low-fat foods,high in refined starches and added sugars Receives: Other: Low-fat, high refined starches/sugars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity index (SI)
SI from a short (50-min) intravenous glucose tolerance test (IVGTT) at baseline(day 0) and end of two treatment periods (day 43 of both treatment periods)
Measured: 43 days for each treatment period.
Secondary outcomes (5)
Fasting lipoprotein lipids
Fasting blood samples will be collected for measurements of lipoprotein lipids including: Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non HDL-C, TC/HDL-C ratio and triglycerides (TG) at all visits.
Measured: Up to 43 days for each treatment period.
Apolipoprotein (Apo) B and A1, Lipoprotein subfractions and particles
Fasting blood samples will be collected for measurements of Apo B1 and A1, and lipoprotein subfractions and particles at baseline (day 0) and end of the two treatment periods (day 43)
Measured: 43 days for each treatment period
high-sensitivity C-reactive protein (hs-CRP)
Fasting blood samples will be collected for measurement of hs-CRP at all visits.
Measured: Up to 43 days
Serum Uric acid
Fasting blood samples will be collected to measure serum Uric acid levels at the beginning and end of each treatment periods.
Measured: 43 days for each treatment period
Interleukin-6 (IL-6)
Fasting blood samples will be collected to measure serum IL-6 levels at baseline (day 0) and the end of the two treatment periods (day 43)
Measured: 43 days for each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start20 Apr 2017
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Study director, Midwest Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126981
- Sponsor's protocol ID
- MB-1701
- Status last verified
- Jul 2019
- First submitted
- 20 Apr 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palacios OM, Maki KC, Xiao D, Wilcox ML, Dicklin MR, Kramer M, Trivedi R, Burton-Freeman B, Edirisinghe I. Effects of Consuming Almonds on Insulin Sensitivity and Other Cardiometabolic Health Markers in Adults With Prediabetes. J Am Coll Nutr. 2020 Jul;39(5):397-406. doi: 10.1080/07315724.2019.1660929. Epub 2019 Sep 16.
PubMed 31525129
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Trial to Assess the Effects of Replacing Refined Carbohydrates With Almonds on Insulin Sensitivity in Men and Women With Prediabetes.
- ClinicalTrials.gov ID
- NCT03126981
- Acronym / sponsor ID
- MB-1701
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 25 Apr 2017 (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.
The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice daily on insulin sensitivity and markers of cardiometabolic health in men and women with prediabetes.
Detailed description
This is a randomized, controlled, two-period crossover study that includes two screening visits, and two 6-week test periods, separated by a 4-week washout. Subjects consume twice daily, 1.5 oz whole, natural almonds (Active Condition) or low-fat foods high in refined starches and added sugars, matched for energy content to the almonds (Control Condition). The assigned study products will be dispensed with instructions to consume 2 servings (Active Product) or 3 servings (Control Products) each day, starting on day 1. Subjects will be screened for prediabetes at the first screening visits. An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period. Fasting blood samples will be collected for lipid profile and high-sensitivity C-reactive protein (hs-CRP) measurements at all visits. Additionally, blood will be drawn for measurement of Apolipoprotein B and A1, lipoprotein particles and subfractions, Interleukin 6 (IL-6) and Uric acid at the beginning and the end of each test period. Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, medication/supplement use, and adverse effects will be performed throughout the study. Compliance will be assessed through a daily log record, and return of unopened study product.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole, natural almonds | Experimental | Other: 1.5 oz of whole, natural almonds1.5 oz of whole, natural almonds |
| Low-fat, high refined starches/sugars | Placebo comparator | Other: Low-fat, high refined starches/sugarsLow-fat foods,high in refined starches and added sugars |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI of 25.0-39.9 kg/m2
- Prediabetic: fingerstick glycated hemoglobin 5.7-6.4% (inclusive), or fasting fingerstick capillary glucose of 100-125 mg/dL (inclusive), or 2-h post-prandial glucose of 140-199 mg/dL.
- Fasting LDL-C level <200 mg/dL and fasting TG level <400 mg/dL.
- Judged to be in general good health on the basis of medical history and screening laboratory tests.
Key exclusion criteria (13 listed)
- Atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound], history of myocardial infarction, angina, a revascularization procedure, or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
- History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type I or type II diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
- Known allergy, sensitivity, or intolerance to any ingredients in the study foods.
- Uncontrolled hypertension.
- Recent history of cancer, except for non-melanoma skin cancer.
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 |
|---|---|---|
| 1.5 oz of whole, natural almonds1.5 oz of whole, natural almonds | Other | Whole, natural almonds |
| Low-fat, high refined starches/sugarsLow-fat foods, high in refined starches and added sugars | Other | Low-fat, high refined starches/sugars |
Primary outcome
Insulin sensitivity index (SI)
Time frame: 43 days for each treatment period.
SI from a short (50-min) intravenous glucose tolerance test (IVGTT) at baseline(day 0) and end of two treatment periods (day 43 of both treatment periods)
5 secondary outcomes
Fasting lipoprotein lipids
Time frame: Up to 43 days for each treatment period.
Apolipoprotein (Apo) B and A1, Lipoprotein subfractions and particles
Time frame: 43 days for each treatment period
high-sensitivity C-reactive protein (hs-CRP)
Time frame: Up to 43 days
Serum Uric acid
Time frame: 43 days for each treatment period
Interleukin-6 (IL-6)
Time frame: 43 days for each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Derived from this study: PubMed 31525129Palacios OM, Maki KC, Xiao D, Wilcox ML, Dicklin MR, Kramer M, Trivedi R, Burton-Freeman B, Edirisinghe I. Effects of Consuming Almonds on Insulin Sensitivity and Other Cardiometabolic Health Markers in Adults With Prediabetes. J Am Coll Nutr. 2020 Jul;39(5):397-406. doi: 10.1080/07315724.2019.1660929. Epub 2019 Sep 16.
- Individual participant dataSharing planned: No
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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.
Kevin Maki, PhD study director
Midwest Biomedical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5 oz of whole, natural almonds and Low-fat, high refined starches/sugars in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin sensitivity index (SI) (time frame: 43 days for each treatment period.). 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 NCT03126981, 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 24 Jul 2019.