OverweightNCT01992783
Resistant Starch, Antioxidant Status and Insulin Resistance
A study testing Hi-maize resistant starch and Maltodextrin in people with Overweight and Obesity, run by Urmia University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate whether supplementation with resistant starch improves biomarkers associated with antioxidant status and insulin resistance in subjects with overweight and obesity. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Hi-maize resistant starch and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteIran
- Study dates
- Aug 2013to Nov 2013
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight and obese adults
- Age: 20-50 years
Who cannot join
- weight loss or gain (more than10%) over the past 6 months, or weight loss (more than 5%) over the past 1 month
- pregnancy, lactation or menopause
- History of acute disease or clinical evidence of cancer, acute or chronic inflammatory diseases, cardiovascular disease, renal disease, liver disease, thyroid or endocrine disease
- Gastrointestinal disease of which ingredients found in the study products have adverse effects on that
- Use of antihypertensive, lipid lowering or glucose lowering medications
- Taking antioxidant, vitamin, and/or mineral supplements
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Resistant Starch Supplementation on Antioxidant Status and Insulin Resistance in Overweight and Obese Adults
The aim of this study is to evaluate whether supplementation with resistant starch improves biomarkers associated with antioxidant status and insulin resistance in subjects with overweight and obesity.
- Conditions
- Overweight, Obesity
- Being tested
- Hi-maize resistant starch, Maltodextrin
- Keywords
- Resistant Starch, Antioxidant Status, Insulin Resistance, Overweight, Obesity
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-maize resistant starchDietary supplement
13.5 g/day
MaltodextrinDietary supplement
13.5 g/day
| Study group | Role | What they receive |
|---|---|---|
| Hi-maize resistant starch | Experimental | 13.5 g/day Receives: Dietary Supplement: Hi-maize resistant starch |
| Maltodextrin | Placebo comparator | 13.5 g/day Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant status
Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)
Measured: 4 weeks
Secondary outcomes (4)
Insulin resistance
Fasting glucose, Fasting insulin, Insulin resistant (HOMA-IR)
Measured: 4 weeks
Lipid profile
Triglyceride, Total cholesterol, HDL-cholesterol, LDL-cholesterol, Total cholesterol/HDL-cholesterol
Measured: 4 weeks
Blood pressure
Measured: 4 weeks
Anthropometric parameters
Height, Weight, Body Mass Index (BMI), Waist circumference
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
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 OverweightStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Alizadeh, PhD, Principal investigator, Assistant Professor in Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992783
- Sponsor's protocol ID
- umsu.rec.1392.75
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2013
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eshghi F, Bakhshimoghaddam F, Rasmi Y, Alizadeh M. Effects of Resistant Starch Supplementation on Glucose Metabolism, Lipid Profile, Lipid Peroxidation Marker, and Oxidative Stress in Overweight and Obese Adults: Randomized, Double-Blind, Crossover Trial. Clin Nutr Res. 2019 Oct 28;8(4):318-328. doi: 10.7762/cnr.2019.8.4.318. eCollection 2019 Oct.
PubMed 31720257
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Resistant Starch Supplementation on Antioxidant Status and Insulin Resistance in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT01992783
- Acronym / sponsor ID
- umsu.rec.1392.75
- Conditions
- Overweight, Obesity
- Keywords
- Resistant Starch, Antioxidant Status, Insulin Resistance, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 25 Nov 2013 (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 aim of this study is to evaluate whether supplementation with resistant starch improves biomarkers associated with antioxidant status and insulin resistance in subjects with overweight and obesity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hi-maize resistant starch | Experimental | Dietary Supplement: Hi-maize resistant starch13.5 g/day |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin13.5 g/day |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Overweight and obese adults
- Age: 20-50 years
Key exclusion criteria (7 listed)
- weight loss or gain (more than10%) over the past 6 months, or weight loss (more than 5%) over the past 1 month
- pregnancy, lactation or menopause
- History of acute disease or clinical evidence of cancer, acute or chronic inflammatory diseases, cardiovascular disease, renal disease, liver disease, thyroid or endocrine disease
- Gastrointestinal disease of which ingredients found in the study products have adverse effects on that
- Use of antihypertensive, lipid lowering or glucose lowering medications
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 |
|---|---|---|
| Hi-maize resistant starch13.5 g/day | Dietary supplement | Hi-maize resistant starch |
| Maltodextrin13.5 g/day | Dietary supplement | Maltodextrin |
Primary outcome
Antioxidant status
Time frame: 4 weeks
Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)
4 secondary outcomes
Insulin resistance
Time frame: 4 weeks
Lipid profile
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Anthropometric parameters
Time frame: 4 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 18 Aug 2015.
- Derived from this study: PubMed 31720257Eshghi F, Bakhshimoghaddam F, Rasmi Y, Alizadeh M. Effects of Resistant Starch Supplementation on Glucose Metabolism, Lipid Profile, Lipid Peroxidation Marker, and Oxidative Stress in Overweight and Obese Adults: Randomized, Double-Blind, Crossover Trial. Clin Nutr Res. 2019 Oct 28;8(4):318-328. doi: 10.7762/cnr.2019.8.4.318. eCollection 2019 Oct.
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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.
Mohammad Alizadeh, PhD principal investigator
Assistant Professor in Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hi-maize resistant starch and Maltodextrin in people with Overweight and Obesity, run by Urmia University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 7 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 Aug 2015. 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 Iran. 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?
Antioxidant status (time frame: 4 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 NCT01992783, 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 18 Aug 2015.