search
Back to results

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

Primary Purpose

Cardiovascular Diseases, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Glucose control
Bread control
Almond paste
Almond paste and inulin
Low dose almond paste and inulin
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Diseases focused on measuring Nuts

Eligibility Criteria

21 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Experimental

Experimental

Experimental

Arm Label

Control: Glucose

Control: Bread

Bread and Almond paste

Bread, Almond paste and Inulin

Bread, Low dose almond paste and Inulin

Arm Description

50 g glucose dissolved in 250 mL water

91.4 g white bread

88.7 g white bread and 15 g almond paste

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

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

Outcomes

Primary Outcome Measures

Postprandial glucose response
Postprandial insulin response
GI calculation for the composite meal

Secondary Outcome Measures

Postprandial low-density lipoprotein cholesterol (LDL) level
Postprandial high-density lipoprotein cholesterol (HDL) level
Postprandial total cholesterol (TC) level
Postprandial triglyceride level

Full Information

First Posted
August 15, 2022
Last Updated
August 29, 2023
Sponsor
Clinical Nutrition Research Centre, Singapore
Collaborators
Glico Asia Pacific Pte Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT05504044
Brief 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
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore
Collaborators
Glico Asia Pacific Pte Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Metabolic Disease
Keywords
Nuts

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control: Glucose
Arm Type
Other
Arm Description
50 g glucose dissolved in 250 mL water
Arm Title
Control: Bread
Arm Type
Other
Arm Description
91.4 g white bread
Arm Title
Bread and Almond paste
Arm Type
Experimental
Arm Description
88.7 g white bread and 15 g almond paste
Arm Title
Bread, Almond paste and Inulin
Arm Type
Experimental
Arm Description
88.7 g white bread, 15 g almond paste and 4 g inulin
Arm Title
Bread, Low dose almond paste and Inulin
Arm Type
Experimental
Arm Description
89.6 g white bread, 10 g almond paste and 3.8 g inulin
Intervention Type
Other
Intervention Name(s)
Glucose control
Intervention Description
50 g glucose dissolved in 250 mL water
Intervention Type
Other
Intervention Name(s)
Bread control
Intervention Description
91.4 g white bread
Intervention Type
Other
Intervention Name(s)
Almond paste
Intervention Description
88.7 g white bread and 15 g almond paste
Intervention Type
Other
Intervention Name(s)
Almond paste and inulin
Intervention Description
88.7 g white bread, 15 g almond paste and 4 g inulin
Intervention Type
Other
Intervention Name(s)
Low dose almond paste and inulin
Intervention Description
89.6 g white bread, 10 g almond paste and 3.8 g inulin
Primary Outcome Measure Information:
Title
Postprandial glucose response
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Postprandial insulin response
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
GI calculation for the composite meal
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Secondary Outcome Measure Information:
Title
Postprandial low-density lipoprotein cholesterol (LDL) level
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Postprandial high-density lipoprotein cholesterol (HDL) level
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Postprandial total cholesterol (TC) level
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Title
Postprandial triglyceride level
Time Frame
0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36329602
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs