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Peanuts Second Meal Glycemic Response

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Peanut, Blood glucose, Insulin, Non-esterified free fatty acids, Glucagon-like peptide-1, Peptide YY, Cholecystokinin, Appetitive, Food intake

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Federal University of Viçosa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Peanut butter

Whole peanut

No peanuts (control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Change in food intake over 24 hours

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

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"

Full Information

NCT ID

NCT01413126

First Posted

August 8, 2011

Last Updated

August 8, 2011

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)

1. Study Identification

Unique Protocol Identification Number

NCT01413126

Brief Title

Peanuts Second Meal Glycemic Response

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Name of the 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)

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peanut butter

Arm Type

Experimental

Arm Description

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

Arm Title

Whole peanut

Arm Type

Experimental

Arm Description

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

Arm Title

No peanuts (control)

Arm Type

No Intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Change from baseline in glucose homeostasis at eight hours

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change from baseline in incretin hormones at four hours

Description

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

Title

Change in food intake over 24 hours

Description

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

Time Frame

24 hours

Title

Change from baseline in appetitive sensations at twelve hours

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials: