Satiety Clinical Trial
Official title:
The Effect of Cooked Whole Navy Beans and Yellow Peas on Short-term Satiety and Food Intake in Children
| NCT number | NCT04396275 |
| Other study ID # | 2017-002 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 1, 2017 |
| Est. completion date | March 31, 2018 |
| Verified date | May 2020 |
| Source | Mount Saint Vincent University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the long-term metabolic effects triggered by regular consumption of pulses. The objective of this study is to investigate the short-term effect of cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary objective is to evaluate how children perceive the sensory characteristics of the meals made with the whole pulses.
| Status | Completed |
| Enrollment | 53 |
| Est. completion date | March 31, 2018 |
| Est. primary completion date | March 31, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 12 Years to 14 Years |
| Eligibility |
Inclusion Criteria: - Healthy boys and girls born at full-term - do not receive any medications Exclusion Criteria: - Food sensitivities or allergies - Dietary restrictions - Health problems - Learning, emotional or behavioral problems. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Mount Saint Vincent University | Halifax | Nova Scotia |
| Lead Sponsor | Collaborator |
|---|---|
| Mount Saint Vincent University |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Food intake | The amount of energy (kcal) consumed ad libitum with the breakfast meal or water control and with the test meal (pizza lunch) two hours later. | 120 min | |
| Primary | Subjective appetite | The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry). | 0-120 min | |
| Primary | Subjective feeling of physical comfort | The subjective assessment of wellness and gastrointestinal symptoms including a feeling of nausea, diarrhea, flatulence, and other parameters measured with 100 mm Visual Analogue Scales with two opposite statements at each end. | 0-120 min | |
| Secondary | Subjective perception of food palatability (pleasantness) | The pleasantness of the meals measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., 0 mm means that food is not pleasant at all, and 100 mm means that the food is very pleasant). | 0, 120 min |
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