Pre-diabetesAV2NCT02695433
Replacing Refined Carbohydrates With Healthy Fats on Cardio-metabolic Markers
A study testing Active in people with Pre-diabetes and Metabolic Syndrome, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI). Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Metabolic Syndrome
- What is being tested?
- Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 15 May 2021
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 25-65 yrs.
- BMI of 25 - 42 kg/m2
- HOMA-IR ≥ 2
- Abdominal obesity: mid-point waist circumference >102 cm for men and >88 cm for women
- No clinical evidence / history of heart disease, respiratory, renal, gastrointestinal, or hepatic disease
- Not taking over-the-counter or prescription medications/dietary supplements that may interfere with study procedures or endpoints (e.g., antioxidant supplements, protein powder, energy drinks, anti-inflammatory or lipid-lowering medications).
- Non-smoker or past smoker (smoking cessation > 2 yrs.)
- Able to provide informed consent and comply with study procedures
Who cannot join
- Aged < 25 or > 65 years
- BMI < 25 kg/m2 or > 42 kg/m2
- HOMA-IR < 2.0
- History of heart disease, respiratory, renal, gastrointestinal or hepatic disease
- Diabetes
- Have or had cancer other than non-melanoma skin cancer in past 5 years
Show all 21Show fewer
- Taking over-the-counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints (including protein powers, energy drinks)
- Vegan dietary habits, unusual dietary habits or sensitive or allergic to any of the test meal components / ingredients
- Consuming 3 or more avocados per week.
- Consuming 3 or more servings of nuts or peanuts per week, unless subject is willing to stop consuming nuts 4 weeks before and throughout the course of the study.
- Excessive coffee and tea consumers (>4 cups/day)
- Current smoker
- Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in 3 months
- Drug or alcohol addiction
- Present with significant psychiatric or neurological disturbances
- Working overnight (e.g 3rd shift of overnight workers)
- Pregnant, lactating or planning to become pregnant
- Have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Women who are taking unstable dose and brand of hormonal contraceptive and/or stable dose and brand less than 6 months
- Excessive exercisers or trained athletes
- Take part in chronic feeding or medication clinical trial in the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Effects of a Typical American Diet High in Refined Carbohydrates Compared to a Diet That Replaces Some Refined Carbohydrates With Healthy Fats on Cardiometabolic Health in Men and Women With Pre-diabetes and Metabolic Syndrome
The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI).
Read the detailed description
The trial is designed as a randomized, controlled, statistician blinded, 2-arm parallel study to investigate the effects of avocado consumption compared to non-avocado control foods which have opposing macronutrients (avocado is relatively higher in fat and in low carbohydrate and the control foods will be low fat, high carbohydrate options) on indices of cardiometabolic health over a 12 week period.
The trial will test 2 treatment conditions in pre-diabetic men and women 25-60 years of age with metabolic syndrome. One hundred twenty men and women will be recruited, aiming for a completer set of 96 subjects. Qualified Subjects will be randomized to receive 1 of 2 test treatments based on randomization schedule from a computer generated randomization schedule.
Study treatments include:
- Control (CT) diet plan with at least 1 serving of a low fat, low fiber, high glycemic carbohydrate and eliminate avocado 7 days / week (5-7 days is acceptable) over a 12 week period.
- Active treatment (AT) diet plan will include 1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period.
Each subject will be asked to come for one Screening Visit, 9 interim food pick-up/compliance visits and 4 Test Day Visits. The four main Test Day visits will occur at week 0 (day 1; baseline), end of week 4, at the end of week 8 and at the end of week 12. Interim Visits will occur at week 1, 2, 3, 5, 6, 7, 9, 10 and 11. Subjects will pick-up study foods, answer questionnaires, receive dietary counseling, confirm diet compliance during interim visits. They will also be asked to complete online 24 hour food recalls up to once per each week of the study. Each of the 4 Test Day Visits will last about 2-3.5 h and involve blood pressure (BP) measurements, a fasting blood sample collection and anthropometric, body composition assessment. In addition, an oral glucose tolerance test (OGTT) will be performed at week 0/day 1 and at the end of week 12/day.
- Conditions
- Pre-diabetes, Metabolic Syndrome
- Being tested
- Active, Control
- Keywords
- Pre-diabetes, Metabolic syndrome, Matsuda composite index of insulin sensitivity (MISI), Blood glucose, Insulin response, HbA1c, Lipid, Inflammation
- Medical subject headings
- Glucose Intolerance, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDietary supplement
Active Treatment Diet Plan
ControlDietary supplement
Control Diet Plan
| Study group | Role | What they receive |
|---|---|---|
| Active treatment (AT) diet plan | Experimental | 1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period Receives: Dietary Supplement: Active |
| Control (CT) diet plan | Placebo comparator | at least 1 serving of a low fat, low fiber, high glycemic carbohydrate and eliminate avocado 7 days / week (5-7 days is acceptable) over a 12 week period Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI) in 12-week intervention of active treatment vs control treatment.
insulin sensitivity as measured by the Matsuda composite index
Measured: baseline and 12 weeks
Secondary outcomes (12)
Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment.
fasting blood glucose response in 12-week intervention
Measured: baseline and 12 weeks
Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment.
fasting blood insulin response in 12-week intervention
Measured: baseline and 12 weeks
Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment.
fasting HbA1c response in 12-week intervention
Measured: baseline and 12 weeks
Changes in blood pressure in 12-week intervention of active treatment vs control treatment.
blood pressure in 12-week intervention
Measured: baseline and 12 weeks
Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment.
fasting blood Triglycerides concentration in 12-week intervention
Measured: baseline and 12 weeks
Changes in fasting hs C-Reactive Protein in 12-week intervention of active treatment vs control treatment.
fasting hs C-Reactive Protein in 12-week intervention
Measured: baseline and 12 weeks
Changes in fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention of active treatment vs control treatment.
fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention
Measured: baseline and 12 weeks
Changes in fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention of active treatment vs control treatment.
fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention
Measured: baseline and 12 weeks
Changes in attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention of active treatment vs control treatment.
attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention
Measured: baseline and 12 weeks
Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs control treatment.
plasma LDL cholesterol in 12-week intervention
Measured: baseline and 12 weeks
Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment.
plasma total cholesterol in 12-week intervention
Measured: baseline and 12 weeks
Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment.
plasma HDL cholesterol in 12-week intervention
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion20 Jan 2021
- Study completion15 May 2021
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 Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695433
- Sponsor's protocol ID
- IRB2016-001
- Acronym
- AV2
- Status last verified
- Jun 2021
- First submitted
- 22 Feb 2016
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhang X, Xiao D, Guzman G, Edirisinghe I, Burton-Freeman B. Avocado Consumption for 12 Weeks and Cardiometabolic Risk Factors: A Randomized Controlled Trial in Adults with Overweight or Obesity and Insulin Resistance. J Nutr. 2022 Aug 9;152(8):1851-1861. doi: 10.1093/jn/nxac126.
PubMed 35700149
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Typical American Diet High in Refined Carbohydrates Compared to a Diet That Replaces Some Refined Carbohydrates With Healthy Fats on Cardiometabolic Health in Men and Women With Pre-diabetes and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02695433
- Acronym / sponsor ID
- AV2 / IRB2016-001
- Conditions
- Pre-diabetes, Metabolic Syndrome
- Keywords
- Pre-diabetes, Metabolic syndrome, Matsuda composite index of insulin sensitivity (MISI), Blood glucose, Insulin response, HbA1c, Lipid, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 1 Mar 2016 (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.
The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI).
Detailed description
The trial is designed as a randomized, controlled, statistician blinded, 2-arm parallel study to investigate the effects of avocado consumption compared to non-avocado control foods which have opposing macronutrients (avocado is relatively higher in fat and in low carbohydrate and the control foods will be low fat, high carbohydrate options) on indices of cardiometabolic health over a 12 week period.
The trial will test 2 treatment conditions in pre-diabetic men and women 25-60 years of age with metabolic syndrome. One hundred twenty men and women will be recruited, aiming for a completer set of 96 subjects. Qualified Subjects will be randomized to receive 1 of 2 test treatments based on randomization schedule from a computer generated randomization schedule.
Study treatments include:
- Control (CT) diet plan with at least 1 serving of a low fat, low fiber, high glycemic carbohydrate and eliminate avocado 7 days / week (5-7 days is acceptable) over a 12 week period.
- Active treatment (AT) diet plan will include 1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period.
Each subject will be asked to come for one Screening Visit, 9 interim food pick-up/compliance visits and 4 Test Day Visits. The four main Test Day visits will occur at week 0 (day 1; baseline), end of week 4, at the end of week 8 and at the end of week 12. Interim Visits will occur at week 1, 2, 3, 5, 6, 7, 9, 10 and 11. Subjects will pick-up study foods, answer questionnaires, receive dietary counseling, confirm diet compliance during interim visits. They will also be asked to complete online 24 hour food recalls up to once per each week of the study. Each of the 4 Test Day Visits will last about 2-3.5 h and involve blood pressure (BP) measurements, a fasting blood sample collection and anthropometric, body composition assessment. In addition, an oral glucose tolerance test (OGTT) will be performed at week 0/day 1 and at the end of week 12/day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment (AT) diet plan | Experimental | Dietary Supplement: Active1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period |
| Control (CT) diet plan | Placebo comparator | Dietary Supplement: Controlat least 1 serving of a low fat, low fiber, high glycemic carbohydrate and eliminate avocado 7 days / week (5-7 days is acceptable) over a 12 week period |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women aged 25-65 yrs.
- BMI of 25 - 42 kg/m2
- HOMA-IR ≥ 2
- Abdominal obesity: mid-point waist circumference >102 cm for men and >88 cm for women
- No clinical evidence / history of heart disease, respiratory, renal, gastrointestinal, or hepatic disease
Key exclusion criteria (21 listed)
- Aged < 25 or > 65 years
- BMI < 25 kg/m2 or > 42 kg/m2
- HOMA-IR < 2.0
- History of heart disease, respiratory, renal, gastrointestinal or hepatic disease
- Diabetes
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 |
|---|---|---|
| ActiveActive Treatment Diet Plan | Dietary supplement | Active treatment (AT) diet plan |
| ControlControl Diet Plan | Dietary supplement | Control (CT) diet plan |
Primary outcome
Changes in insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI) in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
insulin sensitivity as measured by the Matsuda composite index
12 secondary outcomes
Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in blood pressure in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in fasting hs C-Reactive Protein in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment.
Time frame: baseline and 12 weeks
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 29 Jun 2021.
- Derived from this study: PubMed 35700149Zhang X, Xiao D, Guzman G, Edirisinghe I, Burton-Freeman B. Avocado Consumption for 12 Weeks and Cardiometabolic Risk Factors: A Randomized Controlled Trial in Adults with Overweight or Obesity and Insulin Resistance. J Nutr. 2022 Aug 9;152(8):1851-1861. doi: 10.1093/jn/nxac126.
- 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.
Britt Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Pre-diabetes and Metabolic Syndrome, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 8 inclusion and 21 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 29 Jun 2021. 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. 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?
Changes in insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI) in 12-week intervention of active treatment vs control treatment. (time frame: baseline and 12 weeks). 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 NCT02695433, 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 29 Jun 2021.