Dietary Protein Sources and Glycemic Variability

NCT06525441 | Not Yet Recruiting DMC

• 1 other identifier: KY2024-501-03
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

This goal of trial is to evaluate the effects of plant-based vs. animal-based diets on glycemic variability in overweight or obese adults through a 3-week dietary intervention. The main question it aims to answer is: Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared with an animal-based diet? Participants will strictly follow a designated plant-based or animal-based dietary regimen throughout the duration of the 3-week study. They will wear a Continuous Glucose Monitor (CGM) throughout the study, engage in weekly clinical assessments, and record their daily dietary intake.

Conditions

Metabolic Disease; Diabetes; Overweight; Obesity; Dietary Protein

Outcome Measures

Primary Outcomes (1)

• Change in Mean Amplitude of Glycemic Excursion (MAGE)

  Continuous Glucose Monitoring (CGM) will measure the Mean Amplitude of Glycemic Excursion (MAGE).

  From enrollment to the end of intervention at 3 weeks

Secondary Outcomes (21)

• Change in fasting blood-glucose

  From enrollment to the end of intervention at 3 weeks

• Change in fasting insulin

  From enrollment to the end of intervention at 3 weeks

• Change in mean glucose levels

  From enrollment to the end of intervention at 3 weeks

• Change in total daily time above range

  From enrollment to the end of intervention at 3 weeks

• Change in total daily time below range

  From enrollment to the end of intervention at 3 weeks

Study Arms (2)

Plant-based diet

EXPERIMENTAL

Participants assigned to the plant-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The main dietary sources of plant protein will be soybeans, flat beans, nuts, grains, and algae.

Other: Plant-based Diet

Animal-based diet

ACTIVE COMPARATOR

Participants assigned to the animal-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from animal protein, and 25% from fat. The main dietary sources of animal protein will be chicken, beef, pork, fish, eggs, and dairy products.

Other: Animal-based Diet

Interventions

Plant-based Diet OTHER

Participants assigned to the plant-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The main dietary sources of plant protein will be soybeans, flat beans, nuts, grains, and algae.

Plant-based diet

Animal-based Diet OTHER

Participants assigned to the animal-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from animal protein, and 25% from fat. The main dietary sources of animal protein will be chicken, beef, pork, fish, eggs, and dairy products.

Animal-based diet

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 20-65 years.
• Body Mass Index (BMI) greater than 25kg/m2.
• Capable of using a smartphone application daily for taking photos and recording dietary intake.
• Maintained stable body weight over the past three months with a regular routine.
• Possess self-care ability for independent living.
• Not currently participating in any other clinical research projects.
• Signed the informed consent form and willing to adhere to and complete the entire research process.

You may not qualify if:

• With diagnosed diabetes.
• With severe cardiovascular or cerebrovascular diseases (e.g., angina, myocardial infarction, or stroke) or cancer.
• Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician.
• Participating in weight loss treatments.
• History of severe gastrointestinal diseases or gastrointestinal surgery within the past 12 months.
• Those with allergic reactions to common foods (for example, eggs, nuts, grains) or those who are lactose intolerant.
• Women who are pregnant or plan to become pregnant.
• Diagnosis of HIV, hepatitis B or C, or active tuberculosis.
• Special groups who are specifically unsuitable for a diet consisting of whole plant proteins.
• Patients who are unwilling or unable to give informed consent.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

MeSH Terms

Conditions

Metabolic Diseases; Diabetes Mellitus; Overweight; Obesity

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jie Li

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juncheng Zhuang

CONTACT

+86-020-33971424; zhuangjuncheng@gdph.org.cn

Jie Li

CONTACT

+86-020-33971424; lijie4863@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial is an open-label study. Given that dietary intervention will be administered to all participants, it is challenging to implement blinding for the participants. However, throughout the study, the individuals involved in the preparation and distribution of meals, along with those conducting the statistical analysis, will remain blind to the group assignments of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy director of global health research center

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share