Peanuts Second Meal Glycemic Response

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413126
• Other study ID #: NUTBRA
• Status: Completed
• Phase: N/A
• First received: August 8, 2011
• Last updated: August 8, 2011
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: August 2011
• Source: Federal University of Vicosa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Viçosa	Viçosa	Minas Gerais

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Vicosa	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No