High Fat vs High Protein and Appetite Hormones

March 6, 2024 updated by: Nahla Bayyari, Al-Balqa Applied University

Comparing the Effect of High-Fat (Peanuts) Versus High-Protein (Plain Greek Yogurt) Snacks on Appetite Hormones and Satiety Among Overweight and Obese Women

This study will investigate the effects of high-protein, high-fat snacks, specifically Greek yogurt, and peanuts, on satiety, gut hormones, and insulin secretion in overweight and obese women. The hypothesis posited that peanuts will exhibit a more beneficial impact on satiety, gut hormones, and insulin levels compared to Greek yogurt. The two-arm parallel randomized trial will involve 52 participants aged 30 to 40 with a BMI between 25-35 kg/m²,and they will be randomly divided into peanut (n=26) and Greek yogurt (n=26) groups. Pre-snack, BMI and dietary intake will be assessed. Appetite sensations will be gauged using a visual analog scale (VAS) upon arrival, and at 30- and 60-minutes post-snack. Pre- and post-snacking, plasma levels of cholecystokinin (CCK), Peptide Tyrosine-Tyrosine (PYY), Glucagon Like Peptide-1 (GLP-1), Ghrelin (GHRL), and insulin will be analyzed.

Study Overview

Detailed Description

The study's inclusion criteria will be encompassed women aged between 30 and 40 years, with a body mass index (BMI) ranging from 25 to 35 kg/m². These individuals engaged in light exercise 1-3 times per week (activity factor 1.375) and adhered to a routine of consuming three regular meals, along with two daily snacks, and maintaining a water intake of eight cups and do not have allergies to nuts or yogurt.

All participants should adhere to a 1200 kcal diet plan, which included breakfast, snack 1, lunch, snack 2, and dinner. This diet plan will remain consistent for all participants over a consecutive three-day period, except for the snacks that will be provided during the second visit. The specific snack assigned to each participant will be determined based on a predetermined randomization list. The first experimental group (n=26) will receive a high-protein snack in the form of plain Greek yogurt, while the second experimental group (n=26) will receive a high-fat snack in the form of peanuts.

Prior to intervention, in the first visit all anthropometric and body composition assessments will be performed. On the second visit which will be scheduled after three days of adhering to the 1200 Kcal diet, all participants should arrive at the clinic at 1:00 pm and they should had their breakfast at home at 9:00 am. Upon arrival, a baseline blood samples from each participant will be collected.

At 1:00 pm, participants in the plain Greek yogurt and peanut groups will consume their assigned snacks. Following snack consumption, a validated visual analog scale (VAS) questionnaire will be distributed to assess sensations and appetite levels at 0 minutes (1:00 pm), 30 minutes (1:30 pm), and 60 minutes (2:00 pm).

One hour after their arrival, at 2:00 pm, a second blood sample will be collected from all participants. Serum samples will be used to analyze the Ghrelin, PYY, CCK, Glp-1 and insulin using human ELISA kits.

Statistical analysis will be performed after data entry using the SPSS statistical software. Prior to analysis data will be tested for normality. Descriptive statistics for continuous (means± SD) and categorical variables (frequencies and percentages) along with analytical statistics including t-test for paired and unpaired means and the repeated measures for the general linear model will be performed too. P < 0.05 will consider significant.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Al-Balqa
      • As-Salţ, Al-Balqa, Jordan, 19117
        • Nahla S Al-Bayyari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Women aged between 30 and 40 years, with a body mass index (BMI) ranging from 25 to 35 kg/m², engaged in light exercise 1-3 times per week (activity factor 1.375) and adhered to a routine of consuming three regular meals, along with two daily snacks, and maintaining a water intake of eight cups and do not have any allergies, particularly to peanuts, and yogurt.

Exclusion Criteria:

Women aged below 30 years or above 40 years, BMI below 25 kg/m² or above 35 kg/m², engaged in little or no exercise or engaged in moderate to heavy exercise, pregnant or lactating mothers, had allergies to nuts, peanuts, yogurt, milk, or milk products, using medications, hormonal therapy, supplements, oral contraceptives, or herbal/botanical products claimed to suppress appetite. Women in menopausal state, in their menstrual cycle days, or within one week before their menstrual cycle days will be excluded. Those with chronic diseases such as cardiovascular diseases, diabetes, hypertension, kidney diseases, thyroid disorders, gastrointestinal diseases, polycystic ovary syndrome, or androgen disorders, following a weight-reducing diet, experiencing sleep disorders, or sleeping less than 8 hours per day, and consuming less than 8 cups of water per day will also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high fat
26 participants will be provided with (35) g of roasted, not salted peanuts as snack.
Two different types of dietary snacks
Other Names:
  • snack
Experimental: high protein
26 participants will be provided with (380) g of Plain Greek yogurt after as snack.
Two different types of dietary snacks
Other Names:
  • snack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite hormones
Time Frame: one week
The effects of peanut snacking versus plain Greek yogurt on appetite hormones will be measured on Cholecystokinin, Ghrelin, Peptide YY, and Glucagon Like Peptide-1 and Insulin levels
one week
Appetite sensations
Time Frame: 8 weeks
The effect of peanut snacking versus plain Greek yogurt on appetite sensations will be measured using validated visual analog scale (VAS) questionnaire
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Nahla S Al-Bayyari, Ph.D, Al-Balqa Applied University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

October 22, 2023

Study Registration Dates

First Submitted

August 15, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF vs HP-8/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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