Satiety
Conditions
Keywords
whole grain, appetite, glycemic index, leptin, ghrelin
Brief summary
This study is designed to test the hypothesis that whole-grain forms of maize meal enhance and prolong satiety post-meal consumption.
Interventions
OTHERBreakfast 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.
Sponsors
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORHenrietta L de Kock
U Pretoria
Outcome results
None listed