Peanuts Second Meal Glycemic Response

This study has been completed.
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do Estado de Minas Gerais (Brazil)
United States Agency for International Development (USAID)
Information provided by:
Federal University of Vicosa
ClinicalTrials.gov Identifier:
NCT01413126
First received: August 8, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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).


Condition Intervention
Type 2 Diabetes Mellitus
Dietary Supplement: Whole peanuts without skins, Peanut butter, or no peanuts (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Federal University of Vicosa:

Primary Outcome Measures:
  • Change from baseline in glucose homeostasis at eight hours [ Time Frame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430 and 490 minutes ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change from baseline in incretin hormones at four hours [ Time Frame: Baseline (-10), 15, 45, 60, 90, 120, 180 and 240 minutes ] [ Designated as safety issue: No ]
    Postprandial concentrations and the incremental area under the curve of peptide YY and cholecystokinin were assessed after breakfast treatments

  • Change in food intake over 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    All food consumed in laboratory and after leaving the laboratory in the experiment day were recorded

  • Change from baseline in appetitive sensations at twelve hours [ Time Frame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430, 490, 550, 610, 670 and 730 minutes ] [ Designated as safety issue: No ]
    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"


Enrollment: 15
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413126

Locations
Brazil
Federal University of Viçosa
Viçosa, Minas Gerais, Brazil, 36570-000
Sponsors and Collaborators
Federal University of Vicosa
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do Estado de Minas Gerais (Brazil)
United States Agency for International Development (USAID)
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
  More Information

No publications provided

Responsible Party: Rita de Cássia Gonçalves Alfenas, Federal University of Viçosa (Brazil)
ClinicalTrials.gov Identifier: NCT01413126     History of Changes
Other Study ID Numbers: NUTBRA
Study First Received: August 8, 2011
Last Updated: August 8, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Vicosa:
Peanut
Blood glucose
Insulin
Non-esterified free fatty acids
Glucagon-like peptide-1
Peptide YY
Cholecystokinin
Appetitive
Food intake

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014