NCT04769726

Brief Summary

A few studies show the effect of almonds on postprandial hyperglycemia (PPHG); high blood glucose after meals. In our previous study on intervention with almonds, we observed a significant decrease in HbA1C and a small decrease in fasting blood glucose indicating a possible effect of almonds on PPHG. Studies have shown that a preload of a food article that is high in protein, mono-unsaturated fatty acids, fiber, and low in carbohydrates, such as almonds could be helpful in stimulating insulin secretion and help improve postprandial hyperglycemia. The proposed study shall be undertaken to assess the effect of almond supplementation on postprandial hyperglycemia in Asian Indians with prediabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

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

December 16, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3.5 years

First QC Date

February 22, 2021

Last Update Submit

February 18, 2023

Conditions

Intervention

Keywords

almondsAsian IndiansPrediabetes

Outcome Measures

Primary Outcomes (1)

  • Postprandial blood glucose levels [AUC 0-2 hrs on oral glucose tolerance test (OGTT)]

    8 days

Secondary Outcomes (2)

  • postprandial blood glucose levels [AUC 0-4 hrs on continuous glucose monitoring system{CGMS}]

    15 days

  • Postprandial hyperglycaemia (blood glucose levels 2 hrs post OGTT)

    3 months

Study Arms (2)

treatment

EXPERIMENTAL

premeal load of almonds

Dietary Supplement: almonds

control

NO INTERVENTION

standard diet

Interventions

almondsDIETARY_SUPPLEMENT

almond intervention (20 g) before three major meals (60g per day) for 3 days in subacute phase, before OGTT in the acute phase ad for 3 months in chronic phase

treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 60 years
  • Prediabetes as diagnosed on oral glucose tolerance test (OGTT): Fasting blood glucose ≥100mg/dl and \<126 mg/dl and 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 gram anhydrous oral glucose) or 2-h plasma glucose
  • mg/dl and \<200mg/dl alone.

You may not qualify if:

  • Acute infections and advanced end-organ damage
  • History of hepatitis or pancreatitis, abnormal liver and renal functions
  • Recent (\<3 months) changes in weight (≥5%) and/or weight changing medications
  • Any known allergy to nuts
  • uncontrolled hypertension or hypothyroidism
  • suffering from acute infection or any debilitating disease or with renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anoop misra

New Delhi, India

Location

Related Publications (2)

  • Gulati S, Misra A, Tiwari R, Sharma M, Pandey RM, Upadhyay AD, Chandra Sati H. Premeal almond load decreases postprandial glycaemia, adiposity and reversed prediabetes to normoglycemia: A randomized controlled trial. Clin Nutr ESPEN. 2023 Apr;54:12-22. doi: 10.1016/j.clnesp.2022.12.028. Epub 2022 Dec 29.

    PMID: 36963852DERIVED

  • Gulati S, Misra A, Tiwari R, Sharma M, Pandey RM, Upadhyay AD, Sati HC. Beneficial effects of premeal almond load on glucose profile on oral glucose tolerance and continuous glucose monitoring: randomized crossover trials in Asian Indians with prediabetes. Eur J Clin Nutr. 2023 May;77(5):586-595. doi: 10.1038/s41430-023-01263-1. Epub 2023 Feb 2.

    PMID: 36732571DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 24, 2021

Study Start

December 16, 2017

Primary Completion

June 20, 2021

Study Completion

June 20, 2021

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

IN(1)