Type 2 Diabetes MellitusNCT03403582
Raspberries and Postprandial Metabolism
A study testing Raspberries in people with Type 2 Diabetes Mellitus, run by Oklahoma State University at 1 site in United States.
Trial summary
Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown to be potent antioxidants and anti-inflammatory agents. However, human interventional studies reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and inflammation are limited. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Raspberries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2017
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- type 2 diabetes
Who cannot join
- not having type 2 diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Official title: Raspberries, Postprandial Metabolism and Type 2 Diabetes Mellitus
Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown to be potent antioxidants and anti-inflammatory agents. However, human interventional studies reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and inflammation are limited. Aims, objectives and methods:
Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a high-fat fast-food style meal challenge versus control group Objectives: to execute this aim, the investigators will conduct analyses of serum glucose, insulin and lipids (total cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption. The investigators will also calculate homoeostasis model assessment of insulin resistance (HOMA-IR) at these time points using serum glucose and insulin values.
Read more
Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood pressure and artery elasticity) and inflammation following a high-fat fast food style meal challenge versus control group
Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and the following parameters of vascular function associated with CVD at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption:
- systolic blood pressure and diastolic blood pressure
- large artery elasticity index and small artery elasticity index
- systemic vascular resistance
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Raspberries
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaspberriesOther
250g frozen whole red raspberries
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | A high-fat break fast meal with no raspberries. |
| Raspberry arm | Experimental | A high-fat break fast meal with raspberries (250g frozen) Receives: Other: Raspberries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose
Postprandial blood glucose will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Measured: postprandial 4 hours
Postprandial blood lipids
Postprandial blood lipids will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Measured: postprandial 4 hours
Secondary outcomes (1)
Postprandial inflammation
Postprandial C-reactive protein and interleukins will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Measured: postprandial 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study startDec 2014
- Primary completionSep 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arpita Basu, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403582
- Sponsor's protocol ID
- HE1465
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raspberries, Postprandial Metabolism and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03403582
- Acronym / sponsor ID
- HE1465
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Jan 2018 (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.
Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown to be potent antioxidants and anti-inflammatory agents. However, human interventional studies reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and inflammation are limited. Aims, objectives and methods:
Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a high-fat fast-food style meal challenge versus control group Objectives: to execute this aim, the investigators will conduct analyses of serum glucose, insulin and lipids (total cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption. The investigators will also calculate homoeostasis model assessment of insulin resistance (HOMA-IR) at these time points using serum glucose and insulin values.
Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood pressure and artery elasticity) and inflammation following a high-fat fast food style meal challenge versus control group
Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and the following parameters of vascular function associated with CVD at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption:
- systolic blood pressure and diastolic blood pressure
- large artery elasticity index and small artery elasticity index
- systemic vascular resistance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –A high-fat break fast meal with no raspberries. |
| Raspberry arm | Experimental | Other: RaspberriesA high-fat break fast meal with raspberries (250g frozen) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- type 2 diabetes
Key exclusion criteria (1 listed)
- not having type 2 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 |
|---|---|---|
| Raspberries250g frozen whole red raspberries | Other | Raspberry arm |
Primary outcome
Postprandial blood glucose
Time frame: postprandial 4 hours
Postprandial blood glucose will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Postprandial blood lipids
Time frame: postprandial 4 hours
Postprandial blood lipids will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
1 secondary outcome
Postprandial inflammation
Time frame: postprandial 4 hours
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 18 Jan 2018.
- 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 Raspberries in people with Type 2 Diabetes Mellitus, run by Oklahoma 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 1 inclusion and 1 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 18 Jan 2018. 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 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?
Postprandial blood glucose (time frame: postprandial 4 hours). The study lists 2 primary outcomes in all. 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 18 Jan 2018.