Effect of a Protein Supplementation on Body Weight and Metabolic Variables in Overweight and Obese Patients

NCT07549308 | Completed

• 1 other identifier: 2022-0930
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effects of two calorie-restricted diets-one with whey protein supplementation and one without-and a health education control group on weight and metabolic parameters in overweight and obese individuals, with the aim of informing dietary intervention strategies for this population.

Conditions

Overweight; Obesity

Keywords

Overweight and Obesity; Whey Protein; Dietary Pattern

Outcome Measures

Primary Outcomes (1)

• Body weight

  Measured after fasting and voiding, without shoes, in light clothing, using a standard scale

  Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention

Secondary Outcomes (12)

• Skeletal muscle mass

  Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention

• Body fat mass

  Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention

• Body fat percentage

  Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention

• Visceral fat area

  Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention

• Handgrip strength

  Baseline; after 4-week intervention; after 8-week intervention；after 12-week intervention

Study Arms (3)

Whey protein group

EXPERIMENTAL

Participants in the whey protein group underwent a 30% reduction in their average energy intake. They consumed whey protein powder twice daily (13 grams each) with breakfast and afternoon snacks, partially replacing staple foods. The macronutrient distribution for this group was as follows: Carbohydrates: 45%-50% of energy intake Protein: 20%-25% of energy intake Fat: 30% of energy intake The energy-restricted diet lasted for 12 weeks. During this period, clinical nutritionists monitored participants' dietary intake and exercise habits twice a week via WeChat/phone calls. Participants had outpatient visits every 4 weeks for dietary and exercise monitoring and guidance.

Dietary Supplement: whey protein powder

Calorie-restricted balanced diet group

ACTIVE COMPARATOR

Participants in the energy-restricted balanced diet group underwent a 30% reduction in their average energy intake. The macronutrient distribution for this group was as follows: Carbohydrates: 55% of energy intake Protein: 15% of energy intake Fat: 30% of energy intake The energy-restricted diet lasted for 12 weeks. During this period, clinical nutritionists monitored participants' dietary intake and exercise habits twice a week via WeChat/phone calls. Participants had outpatient visits every 4 weeks for dietary and exercise monitoring and guidance.

Behavioral: calorie-restricted balanced diet

Health education control group

ACTIVE COMPARATOR

Participants in the health education control group followed an unrestricted energy healthy diet plan. The macronutrient distribution for this group was as follows: Carbohydrates: 50%-65% of energy intake Protein: 10%-15% of energy intake Fat: 20%-30% of energy intake The intervention lasted for 12 weeks. During this period, clinical nutritionists monitored participants' dietary intake and exercise habits twice a week via WeChat/phone calls. Participants had outpatient visits every 4 weeks for healthy diet and exercise guidance.

Behavioral: health education

Interventions

whey protein powder DIETARY_SUPPLEMENT

The intervention period lasted for 12 weeks. During this time, Participants received dietary guidance from researchers. The whey protein group underwent a 30% energy reduction diet with a macronutrient distribution of 45%-50% carbohydrates, 30% fat, and 20%-25% protein. Participants consumed 13 grams of whey protein powder twice daily, with breakfast and afternoon snacks, partially replacing staple foods.

Whey protein group

calorie-restricted balanced diet BEHAVIORAL

The intervention period lasted for 12 weeks. During this time, Participants received dietary guidance from researchers. The calorie-restricted balanced diet group underwent a 30% energy reduction diet with a macronutrient distribution of 55% carbohydrates, 30% fat, and 15% protein.

Calorie-restricted balanced diet group

health education BEHAVIORAL

The intervention period lasted for 12 weeks. During this time, Participants received dietary guidance from researchers. The health education control diet group followed an unrestricted energy healthy diet plan with a macronutrient distribution of 50% -65%carbohydrates, 20%-30% fat, and 10%-15% protein.

Health education control group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-35 years old, no gender restrictions
• Body mass index (BMI) ≥ 24 kg/m²
• Voluntary consent and signed informed consent form

You may not qualify if:

• Age \< 25 years or \> 35 years
• Current use of medications that may affect weight or energy balance (e.g., lipid-lowering drugs, antidiabetic drugs, appetite suppressants), or other protein supplements
• Presence of acute or chronic viral hepatitis, abnormal liver function (ALT or/and AST \> 3 times the upper limit of normal), kidney disease (serum creatinine \> upper limit of normal), diabetes, malignant tumors, or cardiovascular diseases
• Gastrointestinal disorders that affect food digestion and absorption (e.g., chronic diarrhea, constipation, severe gastrointestinal inflammation, active peptic ulcer disease, post-gastrointestinal surgery)
• Psychiatric disorders
• Allergies to product ingredients or presence of inborn metabolic disorders
• Pregnancy or lactation

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: April 24, 2026
• Study Start: February 23, 2024
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)