Effect of Proteins on Antioxidant Capacity

NCT06621940 | Completed

• 1 other identifier: ERU-BES-AOC-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to provide information about the effect of short-term high protein diet (HPD) feeding on early antioxidant response in women. The definition of HPDs cannot be determined exactly. It is defined differently by various scientific authorities. However, protein is targeted to be approximately 30% of total energy in HPD. It has been determined that HPDs increase satiety, thermogenesis, and provide body weight loss and maintenance of loss. In general, there is evidence that HPD provides more body weight loss in a short time compared to low protein diets. It has been emphasized that the effect of high protein diet on weight loss is related to creating satiety, thus decreasing food intake and increasing thermogenesis. However, the physiological, biochemical and molecular events that occur due to HPD feeding have not been fully understood and the results have not been explained. The effects of HPDs have been determined to last from 1 to 6 days to 6 months. The absence of any study in the literature on the short-term and long-term effects of HPD on oxidative events in humans reveals the original value of this study. Therefore, considering that long-term HPD feeding may increase the risk of cardiovascular disease, blood pressure, and blood lipid levels, the effect of short-term HPD feeding on antioxidant capacity will be investigated in order to avoid these side effects. The planned interviews and measurements for this prospective analytical study will be carried out in the Anthropometry laboratory of the Department of Nutrition and Dietetics, Faculty of Health Sciences at Erciyes University, and blood analyses will be carried out in the Betül Ziya Eren Genome and Stem Cell Research Center laboratory and the Erciyes University Gülser and Dr. Mustafa Gündoğdu Comprehensive Service Laboratory. Healthy female individuals will be applied HPD for 10 days and a normal diet for 10 days as a control. As a result of the applied diets, the expected results of the study are that HPD will cause a decrease in body weight and an increase in lean body mass, even for a short time, and that HPD will have an effect on diet-induced inflammation, cause oxidative stress, affect antioxidant capacity and cause changes in the measured parameters.

Conditions

High Protein Dietary Intake

Keywords

High protein diet; Antioxidant capacity; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (2)

• Antioxidant capacity after high protein diet

  After the diet, antioxidant biomarkers \[antioxidant status (TAS), total oxidant status (TOS)\] will be measured in the blood. Lower values represent a worse outcome.

  Day after diet end

• Anthropometric measurements after high protein diet

  Anthropometric measurements will be made after the diet. An increase in anthropometric measurements represents a worse result.

  Day after diet end

Study Arms (1)

Fixed-Sequence Dietary Intervention

EXPERIMENTAL

All participants received the same fixed sequence of dietary interventions. Participants first received a high-protein diet for 10 days (40% carbohydrate, 30% protein, and 30% fat), followed by a two-week wash-out period during which they maintained their habitual dietary intake. They subsequently received a normal-protein diet for 10 days (55% carbohydrate, 15% protein, and 30% fat). Participants were instructed not to consume foods or beverages other than those permitted by the study protocol during both intervention periods. The intervention order was not randomized.

Other: High Protein Diet; Other: Normal Protein Diet

Interventions

High Protein Diet OTHER

Individuals will be placed on a high protein diet for 10 days.

Fixed-Sequence Dietary Intervention

Normal Protein Diet OTHER

Individuals will be placed on a normal protein diet for 10 days.

Fixed-Sequence Dietary Intervention

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between 19-45 years of age,
• Not changing physical activity throughout the study,
• Having a BMI of 18.5-24.9 kg/m2,
• Being healthy

You may not qualify if:

• Having a BMI of \<18.5 and ≥25 kg/m2,
• Having a chronic disease,
• Smoking and drinking alcohol,
• Using vitamin-mineral supplements and herbal supplements,
• Being pregnant or breastfeeding,
• Having entered menopause,
• Being on any diet.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammation

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study was classified as open-label because all participants received the same fixed intervention sequence. However, laboratory personnel assessing biochemical, oxidative, antioxidant, and inflammatory outcomes were blinded to the dietary intervention periods. Blood samples were coded before analysis and decoded only after all assays had been completed.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: All participants were assigned to a single fixed intervention sequence. Participants first received a high-protein diet for 10 days, followed by a two-week wash-out period, and subsequently received a normal-protein diet for 10 days. The intervention order was not randomized, and there were no parallel intervention groups.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: September 25, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)