High Fat vs High Protein and Appetite Hormones

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dietary Exposure, Hormone Deficiency, Body Weight, Appetitive Behavior

Intervention / Treatment
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* Other: Peanuts or plain Greek yogurt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high fat<br>30 participants will be provided with (33) g of roasted, not salted peanuts after-lunch as snack. | Other: Peanuts or plain Greek yogurt<br>* Two different types of dietary snacks<br>* Other names: snack;|
| Experimental: high protein<br>30 participants will be provided with (148) g of Plain Greek yogurt after-lunch as snack. | Other: Peanuts or plain Greek yogurt<br>* Two different types of dietary snacks<br>* Other names: snack;|
| No Intervention: control<br>30 participants who will not be provided with any type of snacks after lunch | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one week | 
| Body weight | The effect of snacking on peanuts versus Greek plain yogurt on body weight will be assessed by analysing the body composition | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High fat, High protein, Satiety hormones, Appetite, Obesity