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High Fat vs High Protein and Appetite Hormones

Primary Purpose

Body Weight, Appetitive Behavior, Dietary Exposure

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Peanuts or plain Greek yogurt
Sponsored by
Al-Balqa Applied University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Body Weight focused on measuring High fat, High protein, Satiety hormones, Appetite, Obesity

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age between 19 and 50 years, non-smokers, BMI above 25 kg/m² and light active (light exercise 1-3 times/week; activity factor 1.375)
  2. Do not have any chronic disease and not taking any medication or supplements or herbal/botanicals or products claimed to suppress appetite.
  3. Eating a regular snack at least three times per week; and with no known allergies to nuts or control food.

Exclusion Criteria:

  • Aged < 19 and or > 50 years
  • BMI < 25 kg/m²
  • Moderate or active exercise >3 times/week
  • Have any chronic disease
  • on medications or supplements or herbal/botanicals or products claimed to suppress appetite
  • Do not eating a regular snack at least three times per week; and have allergies to nuts or control food.

Sites / Locations

  • Nahla S Al-Bayyari

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

high fat

high protein

control

Arm Description

30 participants will be provided with (33) g of roasted, not salted peanuts after-lunch as snack.

30 participants will be provided with (148) g of Plain Greek yogurt after-lunch as snack.

30 participants who will not be provided with any type of snacks after lunch

Outcomes

Primary Outcome Measures

Appetite hormones
The effect of snacking on peanuts versus Greek plain yogurt on appetite will be measured on Cholecystokinin, Ghrelin, Peptide YY, and Glucagon Like Peptide-1 and Insulin levels
Body weight
The effect of snacking on peanuts versus Greek plain yogurt on body weight will be assessed by analysing the body composition

Secondary Outcome Measures

Full Information

First Posted
August 15, 2020
Last Updated
January 30, 2023
Sponsor
Al-Balqa Applied University
Collaborators
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04518930
Brief Title
High Fat vs High Protein and Appetite Hormones
Official Title
Comparing the Effect of High-Fat (Peanuts) Versus High-Protein (Plain Greek Yogurt) Snacks on Appetite Hormones and Satiety Among Overweight and Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Balqa Applied University
Collaborators
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a randomized control trial, in which ninety women will be conveniently selected but their distribution in a groups will be randomized according to a predetermined randomization list in chronological sequence of inclusion. A three parallel groups, two experimental and one control (labeled A, B and C respectively) will be provided with the same details menu for seven days in except the second snack, depending on their body mass index (BMI); women with BMI 25-30 kg/m² will be provided 1300 calories diet and for women with BMI above 30 kg/m², 1500 calories diet will be provided; in which high protein snack (Plain Greek yogurts) will be provided to the first experimental group (A), high fat snack (peanuts) to the second experimental group (B) and second snack (Plain Greek yogurt or peanuts) will be removed to the control group (C) (Appendix A). The first experimental group (A) will consume (33) g (200) calories of roasted, not salted peanuts after-lunch as snack. The second experimental group (B) will consume (148) g (200) calories of Plain Greek yogurt after-lunch as snack. The control group (C) will consume isoenergetic/equi protein regular three main meals with the first snack only.
Detailed Description
Subjects will be asked to rate their perceptions of hunger. Appetite sensation will be measured using validated visual analog scale (VAS) questionnaire, which provides a quantifiable objective measure translated from subjective sensations. VAS is self-report methodology to assess subjective appetite sensation Each VAS consists of a 100 mm horizontal line, where 0 mm represents sensation not felt at all, while 100 mm sensation felt as the greatest. Participants were asked to place a vertical mark on the 100 mm line to indicate how they feel at testing time (0, 30, 60, and 120 min after the second snack consumption). Participants will be invited to the nutrition clinic at 6:00 pm, upon arrival blood samples will be obtained from each women, intravenous blood samples will be obtained by a trained health care professional (medical laboratory technician) by a trained health care professional using 5 ml capacity syringes from a forearm vein from each woman; one sample will be obtained at the first day of the study at 6:00 pm after one-hour of taking the second snack for group A and B and at same time for group C and another sample will be obtained at the seventh day of the study at the same manner. All blood samples will be analyzed in approved medical laboratory to measure appetite hormones; cholecystokinin, peptide YY, glucagon like peptide-1, and ghrelin on addition to insulin. Two results of each test will be obtained for each woman to observe the change in both results and to study the effect of high protein vs. high fat on appetite hormones to control satiety. Statistical Package for Social Science software (SPSS, version 22.0, 2013) will used to perform the statistical analysis. Repeated measures ANOVA will be used to evaluate VAS scores and hormones' concentration with time and treatment as factors. Some of data and social demographic data will be categorical.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Appetitive Behavior, Dietary Exposure, Hormone Deficiency
Keywords
High fat, High protein, Satiety hormones, Appetite, Obesity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high fat
Arm Type
Experimental
Arm Description
30 participants will be provided with (33) g of roasted, not salted peanuts after-lunch as snack.
Arm Title
high protein
Arm Type
Experimental
Arm Description
30 participants will be provided with (148) g of Plain Greek yogurt after-lunch as snack.
Arm Title
control
Arm Type
No Intervention
Arm Description
30 participants who will not be provided with any type of snacks after lunch
Intervention Type
Other
Intervention Name(s)
Peanuts or plain Greek yogurt
Other Intervention Name(s)
snack
Intervention Description
Two different types of dietary snacks
Primary Outcome Measure Information:
Title
Appetite hormones
Description
The effect of snacking on peanuts versus Greek plain yogurt on appetite will be measured on Cholecystokinin, Ghrelin, Peptide YY, and Glucagon Like Peptide-1 and Insulin levels
Time Frame
one week
Title
Body weight
Description
The effect of snacking on peanuts versus Greek plain yogurt on body weight will be assessed by analysing the body composition
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Overweight and obese females
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 19 and 50 years, non-smokers, BMI above 25 kg/m² and light active (light exercise 1-3 times/week; activity factor 1.375) Do not have any chronic disease and not taking any medication or supplements or herbal/botanicals or products claimed to suppress appetite. Eating a regular snack at least three times per week; and with no known allergies to nuts or control food. Exclusion Criteria: Aged < 19 and or > 50 years BMI < 25 kg/m² Moderate or active exercise >3 times/week Have any chronic disease on medications or supplements or herbal/botanicals or products claimed to suppress appetite Do not eating a regular snack at least three times per week; and have allergies to nuts or control food.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahla S Al-Bayyari, Ph.D
Organizational Affiliation
Al-Balqa Applied University
Official's Role
Study Director
Facility Information:
Facility Name
Nahla S Al-Bayyari
City
As-Salţ
State/Province
Al-Balqa
ZIP/Postal Code
19117
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

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High Fat vs High Protein and Appetite Hormones

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