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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiovascular Diseases, Metabolic Disease

Intervention / Treatment
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* Other: Glucose control
* Other: Bread control
* Other: Almond paste
* Other: Almond paste and inulin
* Other: Low dose almond paste and inulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control: Glucose<br>50 g glucose dissolved in 250 mL water | Other: Glucose control<br>* 50 g glucose dissolved in 250 mL water<br>|
| Other: Control: Bread<br>91.4 g white bread | Other: Bread control<br>* 91.4 g white bread<br>|
| Experimental: Bread and Almond paste<br>88.7 g white bread and 15 g almond paste | Other: Almond paste<br>* 88.7 g white bread and 15 g almond paste<br>|
| Experimental: Bread, Almond paste and Inulin<br>88.7 g white bread, 15 g almond paste and 4 g inulin | Other: Almond paste and inulin<br>* 88.7 g white bread, 15 g almond paste and 4 g inulin<br>|
| Experimental: Bread, Low dose almond paste and Inulin<br>89.6 g white bread, 10 g almond paste and 3.8 g inulin | Other: Low dose almond paste and inulin<br>* 89.6 g white bread, 10 g almond paste and 3.8 g inulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose response |  | 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | 
| Postprandial insulin response |  | 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | 
| GI calculation for the composite meal |  | 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial low-density lipoprotein cholesterol (LDL) level |  | 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | 
| Postprandial high-density lipoprotein cholesterol (HDL) level |  | 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | 
| Postprandial total cholesterol (TC) level |  | 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | 
| Postprandial triglyceride level |  | 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nuts