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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Centre, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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