To Study the Effects of Co-ingesting Different Forms of Almond, Almond Paste, Fibre, and Almond Phytochemicals With Bread on Postprandial Glucose and Insulin Profiles

Cardiovascular Diseases Clinical Trial

Official title:

To Study the Effects of Co-ingesting Different Forms of Almond, Almond Paste, Fibre, and Almond Phytochemicals With Bread on Postprandial Glucose and Insulin Profiles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504044
• Other study ID #: 2019/00701
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: January 18, 2023

Study information

• Verified date: August 2022
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Food is emerging as the new medicine. There has been growing evidence of the beneficial effects of foods, including nuts on human health. Modulation of both glucose and insulin are at the heart of reducing the risk of cardiovascular and other metabolic diseases. The contribution that nuts have on human health has been studied extensively and it is well established that the consumption of nuts revealed improvements in both blood glucose profile and reduced the risk of coronary heart diseases. Nuts, such as almonds, are nutrient-dense foods that are particularly rich in a-tocopherol. They are excellent sources of protein (~25% of energy) and fibre, low in saturated fatty acid content (4-6%) and high in monounsaturated fatty acids. They also contain significant amounts of essential micronutrients such as folate (B vitamin) and polyphenols. Recently, strong interests on the health effects of nuts improving metabolic syndrome and controlling diabetes has been reported. Preliminary studies have indicated that the inclusion of nuts in the diets of individuals with diabetes and/or metabolic syndrome may improve postprandial glycaemic response, and lipid metabolism in the long run.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Chinese Males

• Age: 21-60 years

• Body mass index (BMI) between 18 to 25 kg/m2

• Normal blood pressure (< 140/90 mmHg)

• Fasting blood glucose (FBG) </= 6 mmol/L

Exclusion Criteria:

• People who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug

• People who smoke

• People with any genetic and/or metabolic diseases (such as diabetes, hypertension etc)

• People who have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)

• People with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)

• People who have any severe food allergy (e.g. anaphylaxis to peanuts) or any known food allergy/intolerance

• People who consume fibre supplements or other supplements that is likely to interfere with study outcomes

•• People who have active Tuberculosis (TB) or currently receiving treatment for TB

• People who have any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)

• People who is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

• People is enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.

• People who have intentionally restrict food intake

• People who have poor veins impeding venous access

• People who have any history of severe vasovagal syncope (blackouts or near faints) following blood draws

• People who partake in sports at the competitive and/or endurance levels

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• Glucose control
50 g glucose dissolved in 250 mL water
• Bread control
91.4 g white bread
• Almond paste
88.7 g white bread and 15 g almond paste
• Almond paste and inulin
88.7 g white bread, 15 g almond paste and 4 g inulin
• Low dose almond paste and inulin
89.6 g white bread, 10 g almond paste and 3.8 g inulin

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore	Glico Asia Pacific Pte Ltd

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose response		0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Primary	Postprandial insulin response		0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Primary	GI calculation for the composite meal		0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary	Postprandial low-density lipoprotein cholesterol (LDL) level		0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary	Postprandial high-density lipoprotein cholesterol (HDL) level		0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary	Postprandial total cholesterol (TC) level		0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary	Postprandial triglyceride level		0, 15, 30, 45, 60, 90, 120, 150, 180 minutes