Clinical trial NCT04769726: Pre-meal Load of Raw Almonds and Postprandial Hyperglycemia
Official title: Evaluation of Pre-meal Load of Raw Almonds on Postprandial Hyperglycemia and Other Metabolic Responses in Asian Indians With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Keywords: almonds
Asian Indians
Prediabetes
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
Collaborators: name: National Diabetes Obesity and Cholesterol Foundation
First posted: 2021-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postprandial blood glucose levels [AUC 0-2 hrs on oral glucose tolerance test (OGTT)]
timeFrame: 8 days
Secondary outcomes:
measure: postprandial blood glucose levels [AUC 0-4 hrs on continuous glucose monitoring system{CGMS}]
timeFrame: 15 days
measure: Postprandial hyperglycaemia (blood glucose levels 2 hrs post OGTT)
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Anoop misra
Study officials:
References: