- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02389114
Effect of Soy Protein and Polydextrose on Food Intake in Young Chinese Adult Males
The primary hypothesis of this study is that the higher concentration of soy protein intake will increase satiety and decrease the energy intake at the subsequent meal.
The secondary hypothesis is that the synergistic effect of soy protein and polydextrose will further increase satiety and reduce energy intake at the subsequent meal.
The third hypothesis is that the ingestion of protein and polydextrose will differentially impact on satiety-related metabolism, i.e. blood glucose, insulin, urea, plasma amino acids, gut hormones and gastric emptying.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males
- Chinese ethnicity
- Age between 21-40 years
- Body mass index (BMI) between 18-24 kg/m2
- Healthy
- Normal blood pressure (120/80 mm Hg)
- Fasting blood glucose < 6 mmol/L
Exclusion Criteria:
- Having eating disorders or conscious restriction of food intake
- Partaking in sports at the competitive and endurance levelsHaving allergies/ intolerances to the foods presented in the study
- Having metabolic diseases (diabetes, hypertension and the metabolic syndrome) or chronic gastrointestinal disorders
- Having regime diets (for medical or aesthetic reasons)
- Having medical conditions requiring prescription medication and taking medications known to affect appetite (steroids, sulphonylureas, antihistamines, antidepressants, amphetamines, hypoglycaemic agents and hormones).
- Smoking
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low Protein Preload
The subjects consumed soybean curd preload containing low protein content.
|
Soy protein is commonly consumed in Asian diet.
|
Experimental: Low Protein with Polydextrose Preload
The subjects consumed soybean curd preload containing low protein content and polydextrose.
|
Soy protein is commonly consumed in Asian diet.
Polydextrose is a randomly bonded polymer of glucose developed in the 1960s.
It is widely recognized as a soluble fiber that is not digested in the upper gastrointestinal tract due to the complex structure and nature of the glycosidic bonds, but is partially fermented by the microbiota in large intestine generating short chain fatty acids.
Other Names:
|
Experimental: High Protein Preload
The subjects consumed soybean curd preload containing high protein content.
|
Soy protein is commonly consumed in Asian diet.
|
Experimental: High Protein with Polydextrose Preload
The subjects consumed soybean curd preload containing high protein content and polydextrose.
|
Soy protein is commonly consumed in Asian diet.
Polydextrose is a randomly bonded polymer of glucose developed in the 1960s.
It is widely recognized as a soluble fiber that is not digested in the upper gastrointestinal tract due to the complex structure and nature of the glycosidic bonds, but is partially fermented by the microbiota in large intestine generating short chain fatty acids.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food intake
Time Frame: 90 min subsequent to preload consumption
|
Ad-libitum lunch will be provided to measure food intake
|
90 min subsequent to preload consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective motivational ratings
Time Frame: VAS will be obtained before and after breakfast, 1 and 2 h after breakfast, before preload, 15, 30, 45, 60, and 75 min after the preload, and before and after lunch.
|
Subjective motivational ratings for hunger, fullness, desire to eat and prospective food consumption was measured by the use of visual analogue scales (VAS).
|
VAS will be obtained before and after breakfast, 1 and 2 h after breakfast, before preload, 15, 30, 45, 60, and 75 min after the preload, and before and after lunch.
|
Gastric emptying rate
Time Frame: Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload
|
The rate of gastric emptying was measured by the use of ultrasound scanning.
|
Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload
|
Physiological Outcomes
Time Frame: Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload
|
Blood samples were obtained to analyze glucose, insulin, plasma amino acids, and gut hormones gut hormones
|
Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2013/00383
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