SatietyNCT07204470
The Effects of Four Instant Maize Porridges on Satiety Measures
A study testing Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. in people with Satiety, run by PepsiCo Global R&D at 1 site in South Africa.
Trial summary
This study is designed to test the hypothesis that whole-grain forms of maize meal enhance and prolong satiety post-meal consumption. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety
- What is being tested?
- Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Africa
- Study dates
- 21 Jul 2025to 15 Aug 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Availability to participate on the test days
- Interest and consent to participate in the study
- Participants must be willing to fast 10 hours overnight before the test breakfast meal (only water allowed)
- Products and meals high in fiber, alcohol and strenuous exercise should be avoided 24 hours before the test
- Age 18-35 years
- Healthy BMI: 18.5-24.9 kg/m2
- Equal split, males and females
Who cannot join
- Pregnancy; breast-feeding
- History of gastrointestinal disease having an impact on food absorption or digestion; anorexia nervosa or bulimia nervosa
- Anaemia
- Hypoglycaemia
- Cardiovascular disease; elevated plasma glucose; unstable thyroid function
- Abnormal/irregular menstrual cycle
Show all 13Show fewer
- Substance abuse
- Being on medication which influences appetite
- Depression; smoking
- Participation in any weight altering program; weight gain or loss > 5 kg in 3 months prior to enrolment
- History of intestinal discomfort when consuming relatively small (e.g., <10g) amounts of non-digestible fibres
- Any known food allergies or intolerances such as wheat or soy; special diets prescribed by medical practitioner
- Any intensive physical training program
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to test the hypothesis that whole-grain forms of maize meal enhance and prolong satiety post-meal consumption.
- Conditions
- Satiety
- Being tested
- Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.
- Keywords
- whole grain, appetite, glycemic index, leptin, ghrelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.Other
Cereal is in porridge form. One 350 ml bottle of water provided for the 4 hour test period 7:00-11:00 a.m.. Control dinner meal consumed the prior evening, then fast 10 hours overnight before visiting the test facility on four test days one week apart.
| Study group | Role | What they receive |
|---|---|---|
| Whole grain maize porridge prepared with cold water | Experimental | White Star Whole Grain Instant Maize Porridge Original Receives: Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. |
| Whole grain maize porridge prepared with hot water | Experimental | White Star Whole Grain Instant Maize Porridge Original Receives: Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. |
| Smart Food | Experimental | FUTURELIFE Smart Food Original Receives: Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. |
| Instant Maize Porridge - reduced sugar formulation (WSIP) | Experimental | White Star Instant Maize Porridge Original- reduced sugar formulation (WSIP) Receives: Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety -Appetite
Self-reported appetite ratings using a 100 mm visual analog scale (VAS) questionnaire with 3 items: desire to eat rated from very weak to very strong, hunger rated from not at all to extremely, and fullness rated from not at all to extremely.
Measured: On each of four testing days, in fasted state, immediately after the standardised breakfast (0), and at 120 and 240 min after the breakfast
Satiety -Biomarkers: Leptin
Blood by venipuncture to measure the appetite-regulating hormone leptin in nanograms per milliliter
Measured: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Satiety -Biomarkers: Ghrelin
Blood by venipuncture to measure the appetite-regulating hormone ghrelin in picograms per milliliter
Measured: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Satiety - glycaemic parameters: Glucose
Blood samples obtained by venipuncture in millimoles per liter
Measured: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Satiety - glycaemic parameters: Insulin
Serum samples obtained by venipuncture in microunits per milliliter
Measured: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Secondary outcomes (5)
Anthropometric measurements - BMI
Body mass index calculated from kg weight and cm height
Measured: Test Day 1 only prior to porridge consumption
Anthropometric measurements - WHR
Waist-hip ratio in centimeters
Measured: Test Day 1 only prior to porridge consumption
Anthropometric measurements - Fat Mass
Body composition measurement
Measured: Test Day 1 only prior to porridge consumption
Dietary intake habits-QFFQ
Interviewer-administered, completed once using a quantified food frequency questionnaire (QFFQ) of 140 typically consumed food items by type/brand, cooking methods, frequency, and the amount of all food and drink consumed in the past 4 weeks converted to grams per week per food item
Measured: The protocol allows for completion prior to the first test day, or instead at any one of the four test days. There is no particular time point requirement that it be done at baseline nor within a certain window after test meal consumption.
Dietary intake habits-24 hour recall
Using a quantified food frequency questionnaire (QFFQ)
Measured: Completed at each of the four test days. There is no particular time point requirement that it be done at baseline nor within a certain window after test meal consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start21 Jul 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatietyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrietta L de Kock, Principal investigator, U Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204470
- Sponsor's protocol ID
- PEP-2410
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2025
- Last updated
- 21 Apr 2026
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Four Instant Maize Porridges on Satiety Measures
- ClinicalTrials.gov ID
- NCT07204470
- Acronym / sponsor ID
- PEP-2410
- Conditions
- Satiety
- Keywords
- whole grain, appetite, glycemic index, leptin, ghrelin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 2 Oct 2025 (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.
This study is designed to test the hypothesis that whole-grain forms of maize meal enhance and prolong satiety post-meal consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Whole grain maize porridge prepared with cold water | Experimental | Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.White Star Whole Grain Instant Maize Porridge Original |
| Whole grain maize porridge prepared with hot water | Experimental | Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.White Star Whole Grain Instant Maize Porridge Original |
| Smart Food | Experimental | Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.FUTURELIFE Smart Food Original |
| Instant Maize Porridge - reduced sugar formulation (WSIP) | Experimental | Other: Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.White Star Instant Maize Porridge Original- reduced sugar formulation (WSIP) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Availability to participate on the test days
- Interest and consent to participate in the study
- Participants must be willing to fast 10 hours overnight before the test breakfast meal (only water allowed)
- Products and meals high in fiber, alcohol and strenuous exercise should be avoided 24 hours before the test
- Age 18-35 years
Key exclusion criteria (13 listed)
- Pregnancy; breast-feeding
- History of gastrointestinal disease having an impact on food absorption or digestion; anorexia nervosa or bulimia nervosa
- Anaemia
- Hypoglycaemia
- Cardiovascular disease; elevated plasma glucose; unstable thyroid function
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 |
|---|---|---|
| Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period.Cereal is in porridge form. One 350 ml bottle of water provided for the 4 hour test period 7:00-11:00 a.m.. Control dinner meal consumed the prior evening, then fast 10 hours overnight before visiting the test facility on four test days one week apart. | Other | Instant Maize Porridge - reduced sugar formulation (WSIP), Smart Food, Whole grain maize porridge prepared with cold water, Whole grain maize porridge prepared with hot water |
Primary outcome
Satiety -Appetite
Time frame: On each of four testing days, in fasted state, immediately after the standardised breakfast (0), and at 120 and 240 min after the breakfast
Self-reported appetite ratings using a 100 mm visual analog scale (VAS) questionnaire with 3 items: desire to eat rated from very weak to very strong, hunger rated from not at all to extremely, and fullness rated from not at all to extremely.
Satiety -Biomarkers: Leptin
Time frame: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Blood by venipuncture to measure the appetite-regulating hormone leptin in nanograms per milliliter
Satiety -Biomarkers: Ghrelin
Time frame: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Blood by venipuncture to measure the appetite-regulating hormone ghrelin in picograms per milliliter
Satiety - glycaemic parameters: Glucose
Time frame: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Blood samples obtained by venipuncture in millimoles per liter
Satiety - glycaemic parameters: Insulin
Time frame: On each of four test days at baseline following a 10 hour fast (Time 0), at 2 hours and 4 hours post ingestion of test porridge
Serum samples obtained by venipuncture in microunits per milliliter
5 secondary outcomes
Anthropometric measurements - BMI
Time frame: Test Day 1 only prior to porridge consumption
Anthropometric measurements - WHR
Time frame: Test Day 1 only prior to porridge consumption
Anthropometric measurements - Fat Mass
Time frame: Test Day 1 only prior to porridge consumption
Dietary intake habits-QFFQ
Time frame: The protocol allows for completion prior to the first test day, or instead at any one of the four test days. There is no particular time point requirement that it be done at baseline nor within a certain window after test meal consumption.
Dietary intake habits-24 hour recall
Time frame: Completed at each of the four test days. There is no particular time point requirement that it be done at baseline nor within a certain window after test meal consumption.
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 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Satiety
Active, not recruiting
Postprandial Glycemic and GLP-1 Responses to Modified Full-sugar Drinks
Postprandial Glucose, GLP-1 Concentration
Not yet recruitingPhase 2
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
Obesity & Overweight
Recruiting
Cerebellar TMS and Satiety in Prader-Willi Syndrome
Prader-Willi Syndrome
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
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.
Henrietta L de Kock principal investigator
U Pretoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast cereal standardised to an isocaloric intake of approximately 350 kcal, consume entire portion within 15 minutes witnessed. No other food may be consumed during the 4 hour test period. in people with Satiety, run by PepsiCo Global R&D at 1 site in South Africa.
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 7 inclusion and 13 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 21 Apr 2026. 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 South Africa. 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?
Satiety -Appetite (time frame: On each of four testing days, in fasted state, immediately after the standardised breakfast (0), and at 120 and 240 min after the breakfast). The study lists 5 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 21 Apr 2026.