The Effects of Four Instant Maize Porridges on Satiety Measures

PepsiCo

Status: Enrolling

Conditions: Satiety

Treatments: 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.

Study type: Interventional

Funder types: Industry

Identifiers

NCT07204470

PEP-2410

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 4 patient groups

Whole grain maize porridge prepared with cold water

Experimental group

Description:

White Star Whole Grain Instant Maize Porridge Original

Treatment:

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 group

Description:

White Star Whole Grain Instant Maize Porridge Original

Treatment:

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 group

Description:

FUTURELIFE Smart Food Original

Treatment:

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 group

Description:

White Star Instant Maize Porridge Original- reduced sugar formulation (WSIP)

Treatment:

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.