Skip to main content
OpenTrials
Completed

NCT Number: NCT07204470

The Effects of Four Instant Maize Porridges on Satiety Measures

This study is designed to test the hypothesis that whole-grain forms of maize meal enhance and prolong satiety post-meal consumption.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Satiety

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U. Pretoria

Pretoria, 0083, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Anthropometric measurements - BMI

    Time frame: Test Day 1 only prior to porridge consumption

    Body mass index calculated from kg weight and cm height

  2. Anthropometric measurements - WHR

    Time frame: Test Day 1 only prior to porridge consumption

    Waist-hip ratio in centimeters

  3. Anthropometric measurements - Fat Mass

    Time frame: Test Day 1 only prior to porridge consumption

    Body composition measurement

  4. 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.

    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

  5. 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.

    Using a quantified food frequency questionnaire (QFFQ)

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.