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

NCT ID: NCT05504044

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-25
• Study Completion Date: 2023-01-18

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.

Conditions

Cardiovascular Diseases; Metabolic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Control: Glucose

50 g glucose dissolved in 250 mL water

Group Type: OTHER

Glucose control

Intervention Type: OTHER

50 g glucose dissolved in 250 mL water

Control: Bread

91.4 g white bread

Group Type: OTHER

Bread control

Intervention Type: OTHER

91.4 g white bread

Bread and Almond paste

88.7 g white bread and 15 g almond paste

Group Type: EXPERIMENTAL

Almond paste

Intervention Type: OTHER

88.7 g white bread and 15 g almond paste

Bread, Almond paste and Inulin

88.7 g white bread, 15 g almond paste and 4 g inulin

Group Type: EXPERIMENTAL

Almond paste and inulin

Intervention Type: OTHER

88.7 g white bread, 15 g almond paste and 4 g inulin

Bread, Low dose almond paste and Inulin

89.6 g white bread, 10 g almond paste and 3.8 g inulin

Group Type: EXPERIMENTAL

Low dose almond paste and inulin

Intervention Type: OTHER

89.6 g white bread, 10 g almond paste and 3.8 g inulin

Interventions

Glucose control

50 g glucose dissolved in 250 mL water

Intervention Type: OTHER

Bread control

91.4 g white bread

Intervention Type: OTHER

Almond paste

88.7 g white bread and 15 g almond paste

Intervention Type: OTHER

Almond paste and inulin

88.7 g white bread, 15 g almond paste and 4 g inulin

Intervention Type: OTHER

Low dose almond paste and inulin

89.6 g white bread, 10 g almond paste and 3.8 g inulin

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Glico Asia Pacific Pte Ltd

UNKNOWN

Sponsor Role: collaborator

Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Nutrition Research Centre

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 36329602 (View on PubMed)

Other Identifiers

2019/00701

Identifier Type: -

Identifier Source: org_study_id