The Effects of Four Instant Maize Porridges on Satiety Measures

NCT07204470 | Completed

• 1 other identifier: PEP-2410
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Satiety

Keywords

whole grain; appetite; glycemic index; leptin; ghrelin

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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

  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

  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

  Test Day 1 only prior to porridge consumption

• Anthropometric measurements - WHR

  Test Day 1 only prior to porridge consumption

• Anthropometric measurements - Fat Mass

  Test Day 1 only prior to porridge consumption

• Dietary intake habits-QFFQ

  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

  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.

Study Arms (4)

Whole grain maize porridge prepared with cold water

EXPERIMENTAL

White Star Whole Grain Instant Maize Porridge Original

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

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

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)

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.

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

U. Pretoria

Pretoria, 0083, South Africa

Location

Study Officials

• Henrietta L de Kock

  U Pretoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: July 21, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)