Pre-meal Load of Raw Almonds and Postprandial Hyperglycemia

Evaluation of Pre-meal Load of Raw Almonds on Postprandial Hyperglycemia and Other Metabolic Responses in Asian Indians With Prediabetes

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.

Study Overview

• Status: Completed
• Conditions: Intervention
• Intervention / Treatment: Dietary supplement: almonds

Detailed Description

• Acute Phase Study: Randomized controlled cross over study design Number of arms: 2, almond and control, n=60 needed (30 in each arm) Subjects randomized to almonds arm are given a preload of 20 g of almonds 30 minutes prior to ingestion of 75 g of glucose, while those in the control arm do not have any food/almonds before OGTT. Blood samples are collected at (minutes): -30, 30, 0, 30, 60, 90 and 120. Cross over of these subjects is done and OGTT repeated in a similar manner. Assessment of blood glucose, serum insulin, glucagon, C-peptide, serum triglycerides, free fatty acids, DPP-IV, and GLP1 levels are done at these time points.
• Sub-Acute Study:

Three-day almond preload study monitored with CGMS, n=60 needed. All study participants undergoing OGTT are further studied with CGMS for three days each and then crossed over. Those in almonds arm continue to receive preload of almonds (20g almonds, 30 minutes before breakfast, lunch and dinner)for three days and then studied without almond preload after cross over. A washout period of 7 days separates cross-over period.

o Chronic Phase Study: Ninety days almond preload study monitored with self-monitoring of blood glucose; n=60 needed.

This is a randomized controlled parallel-arm study to evaluate the long-term effect of preload of almonds on hyperglycemia. Subjects fulfilling the inclusion/exclusion criteria are randomized to either the control arm or the almond arm.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi, India
    • Anoop misra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

  • 140mg/dl and <200mg/dl alone.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; premeal load of almonds	Dietary supplement: almonds; 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
No Intervention: control; standard diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postprandial blood glucose levels [AUC 0-2 hrs on oral glucose tolerance test (OGTT)]	8 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India
• Collaborators: National Diabetes Obesity and Cholesterol Foundation

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2017
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prediabetes; Asian Indians; almonds
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: NDOC/11/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No