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

August 29, 2023 updated by: Clinical Nutrition Research Centre, Singapore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Nutrition Research Centre, Singapore

Collaborators

Glico Asia Pacific Pte Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2019

Primary Completion (Actual)

January 18, 2023

Study Completion (Actual)

January 18, 2023

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/00701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Glucose control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe