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Effect of Soy Protein and Polydextrose on Food Intake in Young Chinese Adult Males

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02389114
Enrollment
27
Registered
2015-03-17
Start date
2013-06-30
Completion date
2015-04-30
Last updated
2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Satiety, Diabetes

Brief 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 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).

Interventions

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.

Sponsors

Singapore Institute of Food and Biotechnology Innovation
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
21 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Food intake90 min subsequent to preload consumptionAd-libitum lunch will be provided to measure food intake

Secondary

MeasureTime frameDescription
Subjective motivational ratingsVAS 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).
Gastric emptying rateBefore the preload, and 15, 30, 45, 60, 75 and 90 min after the preloadThe rate of gastric emptying was measured by the use of ultrasound scanning.
Physiological OutcomesBefore the preload, and 15, 30, 45, 60, 75 and 90 min after the preloadBlood samples were obtained to analyze glucose, insulin, plasma amino acids, and gut hormones gut hormones

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026