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Cardiovascular DiseasesNCT05504044

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

A study testing Almond paste, Almond paste and inulin and Low dose almond paste and inulin in people with Cardiovascular Diseases and Metabolic Disease, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Metabolic Disease
What is being tested?
Almond paste, Almond paste and inulin and Low dose almond paste and inulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSingapore
Study dates
25 Oct 2019to 18 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Clinical Nutrition Research Centre

    Singapore, 117599

Other trials in Singapore

About this study

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.

Being tested
Glucose control, Bread control, Almond paste, Almond paste and inulin, Low dose almond paste and inulin
Keywords
Nuts
Medical subject headings
Cardiovascular Diseases, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucose controlOther

    50 g glucose dissolved in 250 mL water

  • Bread controlOther

    91.4 g white bread

  • Almond pasteOther

    88.7 g white bread and 15 g almond paste

  • Almond paste and inulinOther

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

  • Low dose almond paste and inulinOther

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

Study groups in NCT05504044
Study groupRoleWhat they receive
Control: GlucoseOther50 g glucose dissolved in 250 mL water
Receives: Other: Glucose control
Control: BreadOther91.4 g white bread
Receives: Other: Bread control
Bread and Almond pasteExperimental88.7 g white bread and 15 g almond paste
Receives: Other: Almond paste
Bread, Almond paste and InulinExperimental88.7 g white bread, 15 g almond paste and 4 g inulin
Receives: Other: Almond paste and inulin
Bread, Low dose almond paste and InulinExperimental89.6 g white bread, 10 g almond paste and 3.8 g inulin
Receives: Other: Low dose almond paste and inulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postprandial glucose response

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

  2. Postprandial insulin response

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

  3. GI calculation for the composite meal

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

Secondary outcomes (4)

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

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

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

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

  3. Postprandial total cholesterol (TC) level

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

  4. Postprandial triglyceride level

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start25 Oct 2019
  3. Primary completion18 Jan 2023
  4. Study completion18 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05504044
Sponsor's protocol ID
2019/00701
Other IDs
2019
Status last verified
Aug 2022
First submitted
15 Aug 2022
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36329602

Questions about this trial

What is this clinical trial studying?

A study testing Almond paste, Almond paste and inulin and Low dose almond paste and inulin in people with Cardiovascular Diseases and Metabolic Disease, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial glucose response (time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05504044, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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