Co-ingestion of Rice Bran Soymilk or Plain Soymilk With White Bread: Effects on the Glycaemic and Insulinaemic Response

NCT03447080 | Completed

• 1 other identifier: 2017/00286
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

bread and that rice-bran soymilk will have an additional beneficial effect on the glucose and insulin The proposed research project is important because it will provide, for the first time, evidence on the benefits of the addition of rice-bran to soymilk by measuring the acute effect on the glycaemic and insulinaemic response in co-consumption with a high GI meal in Asians. Investigators hypothesize that soymilk will lower the glycaemic and insulinaemic response of white response. This will have an important implication for public health as investigators will understand better how additional dietary fibre can improve the local diet which is typically of high GI values. Ultimately, results from this project will enable the development of dietary recommendations for better glycaemic control in Asian people.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in postprandial blood glucose over 180 minutes period

  Blood obtained through fingerprick, analysed using Hemocue analyser.

  180 minutes

Secondary Outcomes (1)

• Change in postprandial plasma insulin over 180 minutes period

  180 minutes

Study Arms (4)

Control 1

OTHER

White bread

Other: Control

Control 2

OTHER

White bread

Other: Control

Rice bran soybean milk

EXPERIMENTAL

White Bread with 195ml of rice bran soybean mil

Other: Ricebran soybean milk

Soybean milk

EXPERIMENTAL

White Bread with 195ml of soybean milk

Other: Soybean milk

Interventions

Control OTHER

White Bread containing 50g carbohydrate

Control 1

Ricebran soybean milk OTHER

White Bread with rice bran soybean milk

Rice bran soybean milk

Soybean milk OTHER

White Bread with soybean milk

Soybean milk

Eligibility Criteria

• Age: 21 Years - 60 Years
• Gender Eligibility Details: All healthy male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Age between 21-60 years
• Chinese Ethnicity
• Body mass index between 18.5 - 29 kg/m2
• Fasting blood glucose \< 7 mmol/L
• Normal blood pressure (\<140/90 mmHg)

You may not qualify if:

• have metabolic diseases (such as diabetes, hypertension etc.)
• have glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Currently on prescription medication that may affect metabolism
• Intentionally restrict food intake
• Allergic to wheat bread, rice bran and soya bean

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Reseach Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

soybean-milk-coagulating enzyme

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized crossover study

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: June 2, 2017
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

SG (1)