Type 2 DiabetesNCT02868788
Anti-inflammatory Effects of the Fiber
A study testing dietary fiber and HFHC meal in people with Type 2 Diabetes, run by University at Buffalo at 1 site in United States.
Trial summary
This study will help elucidate the mechanism underlying the cardioprotective and anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and oxidative stress markers, based on a contemporary understanding of this process. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- dietary fiber and HFHC meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 to 80 years of age
- Non-smoker (last cigarette at least one month ago)
- Type 2 diabetes for at least 1 year
- Body mass index > 30 kg/m2
Who cannot join
- Participation in any other concurrent clinical trials
- Pregnancy or premenopausal women who are trying to be pregnant
- Patients who are incompetent to give consent
- Patients on non-steroidal anti-inflammatory drugs or steroids
- Concurrent disease that could disrupt intestinal epithelium and increase permeability to endotoxin, ie Celiac and Crohns disease.
- Hepatic disease (transaminase > 3 times normal)
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- Renal impairment (serum creatinine > 1.5 mg/dl)
- History of drug or alcohol abuse
- Use of over the counter or prescribed probiotic supplements.
- Recent or current antibiotic use.
- Coronary artery disease (CAD): documented by history of myocardial infarction, angioplasty/stent placement, angina, exercise EKG positive for ischemia or angiographic evidence of CAD
Trial locations and contacts
1 site in 1 country.
United States1 site
ECMC Ambulatory Center, 3rd Floor
Buffalo, New York, 14215
About this study
Official title: Anti-inflammatory and Reactive Oxygen Species (ROS) Suppressive Effects of the Fiber Supplementation to a High Fat High Carbohydrate Meal and Fiber Supplementation Alone in Obese Patients With Type 2 Diabetes
This study will help elucidate the mechanism underlying the cardioprotective and anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and oxidative stress markers, based on a contemporary understanding of this process. In addition, there have been very few studies that explored the immediate change in oxidative stress and incretin secretion after fiber intake. In this study, the investigators will be able assess the short term metabolic impact of dietary fiber at great details. The result will contribute to dietary recommendation or designing of fiber supplementation for prevention/treatment of diabetes, obesity and cardiovascular disease.
Read the detailed description
Baseline labs include complete blood count (CBC), comprehensive metabolic panel (CMP), Hemoglobin A1C, and lipid profile. All labs will be drawn in the fasting state
Visit 1: Subjects will arrive after having fasted overnight (10 hours) at 7 to 7:30 am. An indwelling intravenous cannula will be placed in the anterior cubital vein for blood draws. A blood sample of the research labs and a urine sample will be collected. Blood pressure, heart rate and weight will be measured. Subjects will consume either a High Fat High Calorie (HFHC) meal or HFHC meal plus fiber (FiberOne Original cereal) according to randomization. Fiber will be consumed before and after the HFHC meal (28 grams in total, 14 grams before and after the meal). HFHC meal includes an egg muffin sandwich, a sausage muffin sandwich and two hash browns which contain 88g carbohydrate, 51 g fat (33% saturated) and 34 g protein. 35 ml of blood will be obtained at 1h , 2h, 3h and 5 h and 5 ml at 15 min,30 min,45 min,75 min and 90 min. A total of 165 ml (11 tablespoon) blood will be collected.
. Visit 2: Subjects will return 1 week later after overnight fasting (10 hours) at 7 to 7:30 am. Blood pressure, heart rate and weight will be measured. Baseline blood and urine samples will be collected again and subjects will be crossed over to receive the second meal (HFHC only or HFHC with fiber). Visit details are similar to visit 1. After this, the subject will be discharged from the study.
- Conditions
- Type 2 Diabetes
- Being tested
- dietary fiber, HFHC meal
- Keywords
- inflammation, insulin resistance, type 2 diabetes, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiberDietary supplement
Also called Fiber One
Fiber one supplement (32 grams of fiber) will be consumed with 910 Calorie HFHC meal
HFHC mealOther
910 Calorie HFHC meal
| Study group | Role | What they receive |
|---|---|---|
| high fat high calorie meal (HFHC) | Other | Subjects in this arm will receive high fat high calorie (HFHC) meal only Receives: Other: HFHC meal |
| HFHC plus fiber | Experimental | Subjects in this arm will receive HFHC meal plus dietary fiber supplementation Receives: Dietary Supplement: dietary fiber; Other: HFHC meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation
mononuclear cells will be isolated by Ficoll-Hypaque method and ROS will be measured by chemiluminescence as an index of NADPH oxidase activation. Measurment will take place at baseline before the meal intervention and hourly for 5 hrs after the meal. The percent change from baseline at peak effect will be calculated.
Measured: 5hr
Secondary outcomes (3)
Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation
Nuclear factor-Kappa B (NFkB) activation will be measured at baseline before the meal and hourly up to 5 hrs and percent change from baseline at peak effect is calculated
Measured: 5hr
Percent Change Toll Like Receptor-4 (TLR-4) Levels
Toll Like Receptor-4 will be measured by Western Blots at baseline before meal intake and hourly up to 5 hrs after meal. Percent change from baseline at peak effect is calculated.
Measured: 5hr
Change in Plasma Lipopolysaccharides Level From Baseline.
Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD). Measurements will take place at baseline before the meals and hourly for next 5 hrs. Percent change from baseline at peak effect is calculated.
Measured: 5hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start14 Jun 2016
- Primary completion1 Jan 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paresh Dandona, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868788
- Sponsor's protocol ID
- 1977
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2016
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory and Reactive Oxygen Species (ROS) Suppressive Effects of the Fiber Supplementation to a High Fat High Carbohydrate Meal and Fiber Supplementation Alone in Obese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02868788
- Acronym / sponsor ID
- 1977
- Conditions
- Type 2 Diabetes
- Keywords
- inflammation, insulin resistance, type 2 diabetes, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help elucidate the mechanism underlying the cardioprotective and anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and oxidative stress markers, based on a contemporary understanding of this process. In addition, there have been very few studies that explored the immediate change in oxidative stress and incretin secretion after fiber intake. In this study, the investigators will be able assess the short term metabolic impact of dietary fiber at great details. The result will contribute to dietary recommendation or designing of fiber supplementation for prevention/treatment of diabetes, obesity and cardiovascular disease.
Detailed description
Baseline labs include complete blood count (CBC), comprehensive metabolic panel (CMP), Hemoglobin A1C, and lipid profile. All labs will be drawn in the fasting state
Visit 1: Subjects will arrive after having fasted overnight (10 hours) at 7 to 7:30 am. An indwelling intravenous cannula will be placed in the anterior cubital vein for blood draws. A blood sample of the research labs and a urine sample will be collected. Blood pressure, heart rate and weight will be measured. Subjects will consume either a High Fat High Calorie (HFHC) meal or HFHC meal plus fiber (FiberOne Original cereal) according to randomization. Fiber will be consumed before and after the HFHC meal (28 grams in total, 14 grams before and after the meal). HFHC meal includes an egg muffin sandwich, a sausage muffin sandwich and two hash browns which contain 88g carbohydrate, 51 g fat (33% saturated) and 34 g protein. 35 ml of blood will be obtained at 1h , 2h, 3h and 5 h and 5 ml at 15 min,30 min,45 min,75 min and 90 min. A total of 165 ml (11 tablespoon) blood will be collected.
. Visit 2: Subjects will return 1 week later after overnight fasting (10 hours) at 7 to 7:30 am. Blood pressure, heart rate and weight will be measured. Baseline blood and urine samples will be collected again and subjects will be crossed over to receive the second meal (HFHC only or HFHC with fiber). Visit details are similar to visit 1. After this, the subject will be discharged from the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high fat high calorie meal (HFHC) | Other | Other: HFHC mealSubjects in this arm will receive high fat high calorie (HFHC) meal only |
| HFHC plus fiber | Experimental | Dietary Supplement: dietary fiber, Other: HFHC mealSubjects in this arm will receive HFHC meal plus dietary fiber supplementation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 18 to 80 years of age
- Non-smoker (last cigarette at least one month ago)
- Type 2 diabetes for at least 1 year
- Body mass index > 30 kg/m2
Key exclusion criteria (11 listed)
- Participation in any other concurrent clinical trials
- Pregnancy or premenopausal women who are trying to be pregnant
- Patients who are incompetent to give consent
- Patients on non-steroidal anti-inflammatory drugs or steroids
- Concurrent disease that could disrupt intestinal epithelium and increase permeability to endotoxin, ie Celiac and Crohns 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 |
|---|---|---|
| dietary fiberAlso: Fiber OneFiber one supplement (32 grams of fiber) will be consumed with 910 Calorie HFHC meal | Dietary supplement | HFHC plus fiber |
| HFHC meal910 Calorie HFHC meal | Other | HFHC plus fiber, high fat high calorie meal (HFHC) |
Primary outcome
Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation
Time frame: 5hr
mononuclear cells will be isolated by Ficoll-Hypaque method and ROS will be measured by chemiluminescence as an index of NADPH oxidase activation. Measurment will take place at baseline before the meal intervention and hourly for 5 hrs after the meal. The percent change from baseline at peak effect will be calculated.
3 secondary outcomes
Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation
Time frame: 5hr
Percent Change Toll Like Receptor-4 (TLR-4) Levels
Time frame: 5hr
Change in Plasma Lipopolysaccharides Level From Baseline.
Time frame: 5hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary fiber and HFHC meal in people with Type 2 Diabetes, run by University at Buffalo 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 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 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?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation (time frame: 5hr). 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 17 Oct 2024.