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Clinical Trials/NCT01413126
NCT01413126
Completed
Not Applicable

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

Federal University of Vicosa1 site in 1 country15 target enrollmentStarted: October 2009Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Federal University of Vicosa
Enrollment
15
Locations
1
Primary Endpoint
Change from baseline in glucose homeostasis at eight hours

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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

  • Type 2 diabetes mellitus
  • Dyslipidemia
  • High blood pressure

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Federal University of Vicosa
Sponsor Class
Other

Study Sites (1)

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