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| Name | Class |
|---|---|
| National Diabetes Obesity and Cholesterol Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | premeal load of almonds |
|
| control | No Intervention | standard diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| almonds | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial blood glucose levels [AUC 0-2 hrs on oral glucose tolerance test (OGTT)] | 8 days |
| Measure | Description | 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 |
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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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anoop misra | New Delhi | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36963852 | Derived | 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. | |
| 36732571 | Derived |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
| D004700 | Endocrine System Diseases |