Peanuts Second Meal Glycemic Response

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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Viçosa, Minas Gerais, Brazil, 36570-000
      • Federal University of Viçosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peanut butter; 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); 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.
Experimental: Whole peanut; 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); 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.
No Intervention: No peanuts (control)	Dietary supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Vicosa
• Collaborators: United States Agency for International Development (USAID); Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo à Pesquisa do estado de Minas Gerais
• Investigators: Principal Investigator: Caio EG Reis, PhD Student, University of Brasília, Brazil; Study Chair: Daniela N Ribeiro, M.Sc., Federal University of Viçosa, Brazil; Study Chair: Neuza MB Costa, Ph.D., Federal University of Espírito Santo, Brazil; Study Chair: Josefina Bressan, Ph.D., Federal University of Viçosa, Brazil; Principal Investigator: Rita CG Alfenas, Ph.D., Federal University of Viçosa, Brazil; Study Director: Richard D Mattes, Ph.D., Purdue University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: August 8, 2011
• First Submitted That Met QC Criteria: August 8, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 8, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Insulin; Cholecystokinin; Food intake; Peanut; Blood glucose; Glucagon-like peptide-1; Peptide YY; Non-esterified free fatty acids; Appetitive
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NUTBRA