Peanuts Second Meal Glycemic Response

NCT01413126 | Completed

• 1 other identifier: NUTBRA
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 2 Diabetes Mellitus

Keywords

Peanut; Blood glucose; Insulin; Non-esterified free fatty acids; Glucagon-like peptide-1; Peptide YY; Cholecystokinin; Appetitive; Food intake

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in incretin hormones at four hours

  Baseline (-10), 15, 45, 60, 90, 120, 180 and 240 minutes

• Change in food intake over 24 hours

  24 hours

• Change from baseline in appetitive sensations at twelve hours

  Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430, 490, 550, 610, 670 and 730 minutes

Study Arms (3)

Peanut butter

EXPERIMENTAL

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)

Whole peanut

EXPERIMENTAL

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)

No peanuts (control)

NO INTERVENTION

Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)

Interventions

Whole peanuts without skins, Peanut butter, or no peanuts (control) DIETARY_SUPPLEMENT

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 peanuts (control); Peanut butter; Whole peanut

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Type 2 diabetes mellitus
• Dyslipidemia
• High blood pressure

Sponsors & Collaborators

• Federal University of Vicosa: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Federal University of Viçosa

Viçosa, Minas Gerais, 36570-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Caio EG Reis, PhD Student

  University of Brasília, Brazil

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

• Rita CG Alfenas, Ph.D.

  Federal University of Viçosa, Brazil

  PRINCIPAL INVESTIGATOR

• Richard D Mattes, Ph.D.

  Purdue University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 10, 2011
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2011
• Last Updated: August 10, 2011

Record last verified: 2011-08

Locations

BR (1)