Peanuts Second Meal Glycemic Response

NCT ID: NCT01413126

Last Updated: 2011-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peanut butter

42.5 g of Peanuts butter were added to a 75g available carbohydrate-matched breakfast meal

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Whole peanut

42.5 g of whole peanuts were added to a 75g available carbohydrate-matched breakfast meal

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Group Type: NO_INTERVENTION

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Federal University of Vicosa

OTHER

Sponsor Role: lead

Responsible Party

Federal University of Viçosa (Brazil)

Principal Investigators

Caio EG Reis, PhD Student

Role: PRINCIPAL_INVESTIGATOR

University of Brasília, Brazil

Daniela N Ribeiro, M.Sc.

Role: STUDY_CHAIR

Federal University of Viçosa, Brazil

Neuza MB Costa, Ph.D.

Role: STUDY_CHAIR

Federal University of Espírito Santo, Brazil

Josefina Bressan, Ph.D.

Role: STUDY_CHAIR

Federal University of Viçosa, Brazil

Rita CG Alfenas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Federal University of Viçosa, Brazil

Richard D Mattes, Ph.D.

Role: STUDY_DIRECTOR

Purdue University

Locations

Federal University of Viçosa

Viçosa, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

NUTBRA

Identifier Type: -

Identifier Source: org_study_id