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

NCT02389114 | Completed

• 1 other identifier: 2013/00383
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Satiety; Diabetes

Outcome Measures

Primary Outcomes (1)

• Food intake

  Ad-libitum lunch will be provided to measure food intake

  90 min subsequent to preload consumption

Secondary Outcomes (3)

• Subjective motivational ratings

  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

  Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload

• Physiological Outcomes

  Before the preload, and 15, 30, 45, 60, 75 and 90 min after the preload

Study Arms (4)

Low Protein Preload

ACTIVE COMPARATOR

The subjects consumed soybean curd preload containing low protein content.

Other: Soy Protein

Low Protein with Polydextrose Preload

EXPERIMENTAL

The subjects consumed soybean curd preload containing low protein content and polydextrose.

Other: Soy Protein; Other: Polydextrose

High Protein Preload

EXPERIMENTAL

The subjects consumed soybean curd preload containing high protein content.

Other: Soy Protein

High Protein with Polydextrose Preload

EXPERIMENTAL

The subjects consumed soybean curd preload containing high protein content and polydextrose.

Other: Soy Protein; Other: Polydextrose

Interventions

Soy Protein OTHER

Soy protein is commonly consumed in Asian diet.

High Protein Preload; High Protein with Polydextrose Preload; Low Protein Preload; Low Protein with Polydextrose Preload

Polydextrose OTHER

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.

Also known as: Litesse

High Protein with Polydextrose Preload; Low Protein with Polydextrose Preload

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Soybean Proteins; polydextrose

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2015-07