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CompletedNCT01413126Updated Aug 10, 2011

Peanuts Second Meal Glycemic Response

An interventional study of Whole peanuts without skins, Peanut butter, or no peanuts (control) in Type 2 Diabetes Mellitus, sponsored by Federal University of Vicosa. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-08-10.

Sponsored by Federal University of Vicosa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Peanut
  • Blood glucose
  • Insulin
  • Non-esterified free fatty acids
  • Glucagon-like peptide-1
  • Peptide YY
  • Cholecystokinin
  • Appetitive
  • Food intake
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 15 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Federal University of Vicosa is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • Dyslipidemia
  • High blood pressure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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)

  • 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)

  • No intervention
    No peanuts (control)

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

Interventions

  • Dietary supplementWhole 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.

06

What researchers measure

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

    Time frame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430 and 490 minutes

Secondary outcomes

  1. 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

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

  2. Change in food intake over 24 hours

    All food consumed in laboratory and after leaving the laboratory in the experiment day were recorded

    Time frame: 24 hours

  3. 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"

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

07

Study locations

1 site
  • Federal University of Viçosa
    Viçosa, Minas Gerais 36570-000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01413126
Lead sponsor
Federal University of Vicosa
Collaborators
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)
First posted
Aug 10, 2011
Start date
Oct 2009
Primary completion
Sep 2010
Completion
Feb 2011
Last update
Aug 10, 2011

Study contacts

Caio EG Reis, PhD Student
principal investigator · University of Brasília, Brazil
Daniela N Ribeiro, M.Sc.
study chair · Federal University of Viçosa, Brazil
Neuza MB Costa, Ph.D.
study chair · Federal University of Espírito Santo, Brazil
Josefina Bressan, Ph.D.
study chair · Federal University of Viçosa, Brazil
Rita CG Alfenas, Ph.D.
principal investigator · Federal University of Viçosa, Brazil
Richard D Mattes, Ph.D.
study director · Purdue University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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