Resistant StarchNCT05108142
Resistant Starch Type-3, Glucose Metabolism and Appetite
A study testing Dietary intervention in people with Resistant Starch, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Resistant starch (RS) is considered to have many of the same health benefits as dietary fiber. The aim of this study was to examine the effects of RS3 on postprandial glycemic and insulinemic responses and appetite. Healthy males (aged 18-35 years) participated in this study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Resistant Starch
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2019to 15 Mar 2020
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Aged between 18 and 40 years
- Normal weight (BMI 18.5-24.9 kg/m2)
- No history of serious disease or currently taking any medications
- Not dieting or seeking to lose weight.
Who cannot join
- Smokers
- Allergy to gluten-containing products, lactose intolerance, or dairy allergy
- Particular dislike to any of the foods provided during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Resistant Starch Type-3 on Glucose Metabolism and Appetite in Healthy Adult Males
Resistant starch (RS) is considered to have many of the same health benefits as dietary fiber. The aim of this study was to examine the effects of RS3 on postprandial glycemic and insulinemic responses and appetite.
Healthy males (aged 18-35 years) participated in this study. Subjects were provided meals in the laboratory after overnight fasting on two separate occasions, at least 1 week apart. On each laboratory visit, subjects were given either a control meal (COM) or an RS3 meal (RSM). Both meals during the two visits consisted of vegetarian pasta and were matched for energy intake, composition, ingredients, and amount, but were prepared in different ways. The COM was hot, freshly cooked pasta, while the RSM was re-heated pasta that had been cooked the previous day and chilled overnight. Blood samples and subjective appetite ratings were collected at fasting and for a period of 3 h after meal consumption (i.e., 15-min intervals for glucose and 30-min intervals for insulin, ghrelin, and subjective appetite).
- Conditions
- Resistant Starch
- Being tested
- Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
fresh, hot pasta and re-heated pasta
| Study group | Role | What they receive |
|---|---|---|
| Control meal | Experimental | Participants were asked to visit the lab and consume the control meal (hot, freshly cooked pasta) Receives: Other: Dietary intervention |
| Resistant starch meal | Experimental | Participants were asked to visit the lab and consume the resistant starch meal (re-heated pasta) Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fasting and postprandial blood glucose concentrations (n=8)
Fasting and postprandial blood glucose assessed with the use of a portable monitor (Accu-Chek) during laboratory visits (before and 3 hours following the meal consumption in the two visits).
Measured: 3 hours
Secondary outcomes (3)
Changes in of fasting and postprandial serum insulin concentrations (n=8)
Fasting and postprandial serum insulin assessed using a commercial kit during laboratory visits (before and 3 hours following the meal consumption in the two visits)
Measured: 3 hours
Changes in subjective appetite ratings (Visual Analogue Scale) (n=8)
Subjective appetite ratings were assessed during laboratory visits (before and 3 hours following the meal consumption in the two visits) with the use of paper-based visual analog scales with words anchored at each end of a 100-mm horizontal line that expressed the most-positive rating and the most-negative rating for a question. The questions were in the form of "How (rating) do you feel?" (with ratings of hungry, satisfied, and full), "How much of a desire to eat?" and "How much do you think you can eat?"
Measured: 3 hours
Changes in fasting and postprandial plasma ghrelin concentrations (n=8)
Fasting and postprandial ghrelin assessed using a commercial kit during laboratory visits (before and 3 hours following the meal consumption in the two visits)
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Nov 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant StarchStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Alhussain, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108142
- Sponsor's protocol ID
- 19/01008
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resistant Starch Type-3 on Glucose Metabolism and Appetite in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT05108142
- Acronym / sponsor ID
- 19/01008
- Conditions
- Resistant Starch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 4 Nov 2021 (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.
Resistant starch (RS) is considered to have many of the same health benefits as dietary fiber. The aim of this study was to examine the effects of RS3 on postprandial glycemic and insulinemic responses and appetite.
Healthy males (aged 18-35 years) participated in this study. Subjects were provided meals in the laboratory after overnight fasting on two separate occasions, at least 1 week apart. On each laboratory visit, subjects were given either a control meal (COM) or an RS3 meal (RSM). Both meals during the two visits consisted of vegetarian pasta and were matched for energy intake, composition, ingredients, and amount, but were prepared in different ways. The COM was hot, freshly cooked pasta, while the RSM was re-heated pasta that had been cooked the previous day and chilled overnight. Blood samples and subjective appetite ratings were collected at fasting and for a period of 3 h after meal consumption (i.e., 15-min intervals for glucose and 30-min intervals for insulin, ghrelin, and subjective appetite).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control meal | Experimental | Other: Dietary interventionParticipants were asked to visit the lab and consume the control meal (hot, freshly cooked pasta) |
| Resistant starch meal | Experimental | Other: Dietary interventionParticipants were asked to visit the lab and consume the resistant starch meal (re-heated pasta) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males
- Aged between 18 and 40 years
- Normal weight (BMI 18.5-24.9 kg/m2)
- No history of serious disease or currently taking any medications
- Not dieting or seeking to lose weight.
Key exclusion criteria (3 listed)
- Smokers
- Allergy to gluten-containing products, lactose intolerance, or dairy allergy
- Particular dislike to any of the foods provided during the study.
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 interventionfresh, hot pasta and re-heated pasta | Other | Control meal, Resistant starch meal |
Primary outcome
Changes in fasting and postprandial blood glucose concentrations (n=8)
Time frame: 3 hours
Fasting and postprandial blood glucose assessed with the use of a portable monitor (Accu-Chek) during laboratory visits (before and 3 hours following the meal consumption in the two visits).
3 secondary outcomes
Changes in of fasting and postprandial serum insulin concentrations (n=8)
Time frame: 3 hours
Changes in subjective appetite ratings (Visual Analogue Scale) (n=8)
Time frame: 3 hours
Changes in fasting and postprandial plasma ghrelin concentrations (n=8)
Time frame: 3 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 15 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Resistant Starch
Recruiting
Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits
Fasting, Dietary Fibre
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
RecruitingPhase 2
Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Allogeneic Stem Cell Transplant
RecruitingPhase 2
Combined Oral Contraceptive Pill and Resistance Starch
Metabolic Syndrome, Polycystic Ovary Syndrome
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
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 intervention in people with Resistant Starch, run by King Saud University at 1 site in Saudi Arabia.
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 5 inclusion and 3 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 15 Nov 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 Saudi Arabia. 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?
Changes in fasting and postprandial blood glucose concentrations (n=8) (time frame: 3 hours). 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 15 Nov 2021.