The Effects of Four Instant Maize Porridges on Satiety Measures

Not Applicable

Recruiting

• Conditions: Satiety

• Registration Number: NCT07204470
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-21
• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Satiety -Appetite	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	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	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	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	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 Outcome Measures

Name	Time	Method
Anthropometric measurements - BMI	Test Day 1 only prior to porridge consumption	Body mass index calculated from kg weight and cm height
Anthropometric measurements - WHR	Test Day 1 only prior to porridge consumption	Waist-hip ratio in centimeters
Anthropometric measurements - Fat Mass	Test Day 1 only prior to porridge consumption	Body composition measurement
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.	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
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.	Using a quantified food frequency questionnaire (QFFQ)

Trial Locations

Locations (1)

U. Pretoria; 🇿🇦 Pretoria, South Africa