Peanuts Second Meal Glycemic Response

Study Overview
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Brief Summary
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Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study was to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic, insulinemic and selected gut hormone responses, appetite, and food intake over two consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated in a randomized crossover trial where 42.5g of whole peanuts (P), peanut butter (PB), or no peanuts (control-C) were added to a 75g available carbohydrate-matched breakfast meal. Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive sensations and food intake were assessed after breakfast treatments and a standard lunch (75g available carbohydrate).

Official Title
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Acute and Second Meal Effects of Peanuts on Glycemic Response and Appetite in Obese Women With High Type 2 Diabetes Risk: a Randomized Crossover Trial

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 30 - 35 kg/M2 Not taking medications known to affect glycemia, fat metabolism, or appetite Regular breakfast consumer (≥100 kilocalories ingested within 2 hours of waking on ≥4d/wk) No body weight fluctuation (<5kg in the past 3 months) Willingness to eat all test foods No self-reported allergy to the foods provided in the study No self-reported sleep disorders At least one of the following conditions: waist circumference ≥ 88 cm; reported family history of Type 2 diabetes in first degree relatives; capillary glycemia between 5.5 - 7.0 mmol/L; and/or a 2-hour blood glucose of 7.8 - 11.1 mmol/L (impaired glucose tolerance) Exclusion Criteria: Type 2 diabetes mellitus Dyslipidemia High blood pressure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peanut butter<br>42.5 g of Peanuts butter were added to a 75g available carbohydrate-matched breakfast meal | Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)<br>* In accordance with the Food and Drug Administration qualified health claim regarding daily nut intake, 42.5 g of whole peanuts or peanut butter were added to a 75g available carbohydrate-matched breakfast meal each test session.<br>|
| Experimental: Whole peanut<br>42.5 g of whole peanuts were added to a 75g available carbohydrate-matched breakfast meal | Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)<br>* In accordance with the Food and Drug Administration qualified health claim regarding daily nut intake, 42.5 g of whole peanuts or peanut butter were added to a 75g available carbohydrate-matched breakfast meal each test session.<br>|
| No Intervention: No peanuts (control)<br> | Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)<br>* In accordance with the Food and Drug Administration qualified health claim regarding daily nut intake, 42.5 g of whole peanuts or peanut butter were added to a 75g available carbohydrate-matched breakfast meal each test session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glucose homeostasis at eight hours | Postprandial concentrations and incremental area under the curve of blood glucose, insulin and glucagon-like peptide-1, and incremental area above the curve of non-esterified free fatty acids were assessed after breakfast treatments and a standard lunch | Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430 and 490 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in incretin hormones at four hours | Postprandial concentrations and the incremental area under the curve of peptide YY and cholecystokinin were assessed after breakfast treatments | Baseline (-10), 15, 45, 60, 90, 120, 180 and 240 minutes | 
| Change in food intake over 24 hours | All food consumed in laboratory and after leaving the laboratory in the experiment day were recorded | 24 hours | 
| Change from baseline in appetitive sensations at twelve hours | Appetite ratings were scored at baseline and in a pre-determined times on a 100 mm visual analogue scale anchored with descriptors of not at all and extremely | Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430, 490, 550, 610, 670 and 730 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut, Blood glucose, Insulin, Non-esterified free fatty acids, Glucagon-like peptide-1, Peptide YY, Cholecystokinin, Appetitive, Food intake