NCT05504044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

August 15, 2022

Last Update Submit

August 29, 2023

Conditions

Cardiovascular DiseasesMetabolic Disease

Keywords

Nuts

Outcome Measures

Primary Outcomes (3)

  • Postprandial glucose response

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

  • Postprandial insulin response

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

  • GI calculation for the composite meal

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

Secondary Outcomes (4)

  • Postprandial low-density lipoprotein cholesterol (LDL) level

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

  • Postprandial high-density lipoprotein cholesterol (HDL) level

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

  • Postprandial total cholesterol (TC) level

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

  • Postprandial triglyceride level

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

Study Arms (5)

Control: Glucose

OTHER

50 g glucose dissolved in 250 mL water

Other: Glucose control

Control: Bread

OTHER

91.4 g white bread

Other: Bread control

Bread and Almond paste

EXPERIMENTAL

88.7 g white bread and 15 g almond paste

Other: Almond paste

Bread, Almond paste and Inulin

EXPERIMENTAL

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

Other: Almond paste and inulin

Bread, Low dose almond paste and Inulin

EXPERIMENTAL

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

Other: Low dose almond paste and inulin

Interventions

Glucose controlOTHER

50 g glucose dissolved in 250 mL water

Control: Glucose
Bread controlOTHER

91.4 g white bread

Control: Bread
Almond pasteOTHER

88.7 g white bread and 15 g almond paste

Bread and Almond paste
Almond paste and inulinOTHER

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

Bread, Almond paste and Inulin
Low dose almond paste and inulinOTHER

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

Bread, Low dose almond paste and Inulin

Eligibility Criteria

Age21 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 36329602DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic Diseases

Interventions

Glycemic ControlInulin

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

October 25, 2019

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

August 31, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)