Clinical trial NCT05504044: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Disease
Keywords: Nuts
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Glico Asia Pacific Pte Ltd
First posted: 2022-08-17
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Postprandial glucose response
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Postprandial insulin response
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: GI calculation for the composite meal
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary outcomes:
measure: Postprandial low-density lipoprotein cholesterol (LDL) level
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Postprandial high-density lipoprotein cholesterol (HDL) level
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Postprandial total cholesterol (TC) level
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
measure: Postprandial triglyceride level
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References:
citation: Bi X, Yeo MTY, Jeyakumar Henry C. Almond paste and dietary fibre: a novel way to improve postprandial glucose and lipid profiles? Int J Food Sci Nutr. 2022 Dec;73(8):1124-1131. doi: 10.1080/09637486.2022.2141207. Epub 2022 Nov 3.