Pre-meal Load of Raw Almonds and Postprandial Hyperglycemia

NCT ID: NCT04769726

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-16
• Study Completion Date: 2021-06-20

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.

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.

Conditions

Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

treatment

premeal load of almonds

Group Type: EXPERIMENTAL

almonds

Intervention Type: DIETARY_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

control

standard diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Diabetes Obesity and Cholesterol Foundation

OTHER

Sponsor Role: collaborator

Diabetes Foundation, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anoop misra

New Delhi, , India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 36963852 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36732571 (View on PubMed)

Other Identifiers

NDOC/11/2017

Identifier Type: -

Identifier Source: org_study_id