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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Cardiovascular Diseases Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Centre

Singapore, 117599

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose control

Other

50 g glucose dissolved in 250 mL water

Bread control

Other

91.4 g white bread

Almond paste

Other

88.7 g white bread and 15 g almond paste

Almond paste and inulin

Other

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

Low dose almond paste and inulin

Other

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

Primary outcomes

  1. Postprandial glucose response

    Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  2. Postprandial insulin response

    Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  3. GI calculation for the composite meal

    Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

Secondary outcomes

  1. Postprandial low-density lipoprotein cholesterol (LDL) level

    Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  2. Postprandial high-density lipoprotein cholesterol (HDL) level

    Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  3. Postprandial total cholesterol (TC) level

    Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

  4. Postprandial triglyceride level

    Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Collaborators

  • Glico Asia Pacific Pte Ltd

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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