ObesityNCT02389114
Effect of Soy Protein and Polydextrose on Food Intake in Young Chinese Adult Males
A study testing Soy Protein and Polydextrose in people with Obesity and Satiety, run by Singapore Institute of Food and Biotechnology Innovation.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- What is being tested?
- Soy Protein and Polydextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the detailed description
Soy foods have been part of Asian food systems for millennia. In the past decades, both soy proteins and polydextrose have been widely used in a variety of food products. Helping consumers to feel less hungry is an approach to weight management because it has the potential to decrease inter-meal hunger and hence reduce overall energy intake. Considering the possible satiety effect of soy protein and polydextrose, inclusion of these molecules in the diet could therefore potentially reduce the energy intake and assist with weight management in order to attenuate the rise in obesity incidence globally. The study will provide data for the first time on how soy protein and soluble fiber impact on satiety and acute energy intake in those of Chinese ethnic origin. The research sets out to determine the effect of soy protein and polydextrose on satiety and food intake in Asians. It specifically attempts to comprehend the physiological mechanisms involving blood glucose, insulin, urea, plasma amino acids, gut hormones and the rate of gastric emptying of soy protein and polydextrose on appetite ratings, satiety and subsequent food intake. The study will recruit healthy young Chinese male, who will return for four test sessions on non-consecutive days. At each session, the subjects will be given a standard breakfast, followed 180 min later by a soybean curd preload and a buffet lunch 90 min after the preload. Four preloads will be tested: (1) low protein, (2) high protein, (3) low protein with polydextrose, and (4) high protein with polydextrose. Each soybean curd preload will be tested once by each subject. Blood samples from cannulated veins and fingerpricks will be collected before the preload, 15, 30, 45, 60, 75 and 90 min after the preload for the analysis of glucose, insulin, urea, plasma amino acids, and gut hormones. At the same time points as when blood samples collected, gastric emptying measurements will be carried out using ultrasound. Subjective motivational ratings for hunger, fullness, desire to eat and prospective food consumption will be measured by the use of visual analogue scales (VAS).
- Being tested
- Soy Protein, Polydextrose
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy ProteinOther
Soy protein is commonly consumed in Asian diet.
PolydextroseOther
Also called Litesse
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Protein Preload | Active comparator | The subjects consumed soybean curd preload containing low protein content. Receives: Other: Soy Protein |
| Low Protein with Polydextrose Preload | Experimental | The subjects consumed soybean curd preload containing low protein content and polydextrose. Receives: Other: Soy Protein; Other: Polydextrose |
| High Protein Preload | Experimental | The subjects consumed soybean curd preload containing high protein content. Receives: Other: Soy Protein |
| High Protein with Polydextrose Preload | Experimental | The subjects consumed soybean curd preload containing high protein content and polydextrose. Receives: Other: Soy Protein; Other: Polydextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Ad-libitum lunch will be provided to measure food intake
Measured: 90 min subsequent to preload consumption
Secondary outcomes (3)
Subjective motivational ratings
Subjective motivational ratings for hunger, fullness, desire to eat and prospective food consumption was measured by the use of visual analogue scales (VAS).
Measured: 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
The rate of gastric emptying was measured by the use of ultrasound scanning.
Measured: Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload
Physiological Outcomes
Blood samples were obtained to analyze glucose, insulin, plasma amino acids, and gut hormones gut hormones
Measured: Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389114
- Sponsor's protocol ID
- 2013/00383
- Status last verified
- Jul 2015
- First submitted
- 10 Mar 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soy Protein and Polydextrose on Food Intake in Young Chinese Adult Males
- ClinicalTrials.gov ID
- NCT02389114
- Acronym / sponsor ID
- 2013/00383
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Soy foods have been part of Asian food systems for millennia. In the past decades, both soy proteins and polydextrose have been widely used in a variety of food products. Helping consumers to feel less hungry is an approach to weight management because it has the potential to decrease inter-meal hunger and hence reduce overall energy intake. Considering the possible satiety effect of soy protein and polydextrose, inclusion of these molecules in the diet could therefore potentially reduce the energy intake and assist with weight management in order to attenuate the rise in obesity incidence globally. The study will provide data for the first time on how soy protein and soluble fiber impact on satiety and acute energy intake in those of Chinese ethnic origin. The research sets out to determine the effect of soy protein and polydextrose on satiety and food intake in Asians. It specifically attempts to comprehend the physiological mechanisms involving blood glucose, insulin, urea, plasma amino acids, gut hormones and the rate of gastric emptying of soy protein and polydextrose on appetite ratings, satiety and subsequent food intake. The study will recruit healthy young Chinese male, who will return for four test sessions on non-consecutive days. At each session, the subjects will be given a standard breakfast, followed 180 min later by a soybean curd preload and a buffet lunch 90 min after the preload. Four preloads will be tested: (1) low protein, (2) high protein, (3) low protein with polydextrose, and (4) high protein with polydextrose. Each soybean curd preload will be tested once by each subject. Blood samples from cannulated veins and fingerpricks will be collected before the preload, 15, 30, 45, 60, 75 and 90 min after the preload for the analysis of glucose, insulin, urea, plasma amino acids, and gut hormones. At the same time points as when blood samples collected, gastric emptying measurements will be carried out using ultrasound. Subjective motivational ratings for hunger, fullness, desire to eat and prospective food consumption will be measured by the use of visual analogue scales (VAS).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Protein Preload | Active comparator | Other: Soy ProteinThe subjects consumed soybean curd preload containing low protein content. |
| Low Protein with Polydextrose Preload | Experimental | Other: Soy Protein, Other: PolydextroseThe subjects consumed soybean curd preload containing low protein content and polydextrose. |
| High Protein Preload | Experimental | Other: Soy ProteinThe subjects consumed soybean curd preload containing high protein content. |
| High Protein with Polydextrose Preload | Experimental | Other: Soy Protein, Other: PolydextroseThe subjects consumed soybean curd preload containing high protein content and polydextrose. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males
- Chinese ethnicity
- Age between 21-40 years
- Body mass index (BMI) between 18-24 kg/m2
- Healthy
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy ProteinSoy protein is commonly consumed in Asian diet. | Other | High Protein Preload, High Protein with Polydextrose Preload, Low Protein Preload, Low Protein with Polydextrose Preload |
| PolydextroseAlso: LitessePolydextrose 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 | High Protein with Polydextrose Preload, Low Protein with Polydextrose Preload |
Primary outcome
Food intake
Time frame: 90 min subsequent to preload consumption
Ad-libitum lunch will be provided to measure food intake
3 secondary outcomes
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.
Gastric emptying rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Soy Protein and Polydextrose in people with Obesity and Satiety, run by Singapore Institute of Food and Biotechnology Innovation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: 90 min subsequent to preload consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.