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Completed

NCT Number: NCT01413126

Peanuts Second Meal Glycemic Response

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Viçosa

Viçosa, Minas Gerais, 36570-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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 outcomes

  1. Change from baseline in incretin hormones at four hours

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

    Postprandial concentrations and the incremental area under the curve of peptide YY and cholecystokinin were assessed after breakfast treatments

  2. Change in food intake over 24 hours

    Time frame: 24 hours

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

  3. 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

    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"

Sponsors and collaborators

Lead sponsor

Federal University of Vicosa

Other

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)

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 10, 2011
Registry last updated
Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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