Metabolic Response to Variations in Dietary Glycemic Index

NCT05804942 | Completed

• 1 other identifier: SIAT-IRB-221115-H0618
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare metabolic response to variations in dietary glycemic index in healthy participants. The main questions it aims to answer are: • What are the metabolic hunger and food intake responses to different levels of glycemic index on the background of otherwise constant macronutrient composition? Participants will come to the lab after an overnight fast and body composition will be tested by bio-impedance analysis and magnetic resonance imaging. They will then be randomized to eat one of three standardized breakfasts varying in the glycemic index. Circulating glucose levels will be monitored using a continuous glucose monitor and blood samples will be collected to measure metabolic and hormone factors in the serum. Participants will also rate their hunger at 0, 30, 60, 120, 180, 240 and 300 minutes. After 5 hours they will eat a free choice meal from a standardized selection buffet (test meal).

Conditions

Healthy; Hunger; Food Preferences

Keywords

carbohydrate insulin model; circulating factors

Outcome Measures

Primary Outcomes (1)

• Change in energy intake of test meal between day 0 and day 1

  The food intake will be assessed objectively by use of a feeding table. The test meal will be provided as lunch, and food types available on the table include staples, vegetables, mushrooms, meat, soy products, desserts, beverages and water. All types of food are unlimited. Food consumption will be recorded continuously by balances concealed under each food dish. The food energy density for each food will be measured by bomb calorimetry in kJ/g, and energy intake will be calculated as the product of the grams of each food eaten multiplied by the respective energy density and then summed, as kJ. This test meal intake is measured on day 0 and then a repeat test meal measure is made under identical conditions on day 1. On day 1 an intervention meal is also consumed five hours before the test meal is consumed. On day 0 no such meal is consumed. The outcome measure is the change in food intake (kJ) between day 0 and day 1 reflecting the impact of the intervention meal.

  Change in intake between day 0 and day 1

Secondary Outcomes (4)

• circulating hormones

  fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.

• postprandial glucose

  fasting glucose and postprandial glucose for 5 hours

• self reported hunger

  fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.

• levels of circulating metabolic fuels

  fasting, postprandial 30, 60, 120, 180, 240 and 300 minutes.

Other Outcomes (11)

• fat mass tested by bioelectrical impedance analysis

  pre measurement

• fat mass tested by magnetic resonance imaging

  pre measurement

• fat free mass tested by bioelectrical impedance analysis

  pre measurement

Study Arms (3)

High glycemic index

EXPERIMENTAL

The participants will be fed a fixed calorie meal, which is high glycemic index with constant fat and protein.

Behavioral: High glycemic index

Medium glycemic index

EXPERIMENTAL

The participants will be fed a fixed calorie meal, which is medium glycemic index with constant fat and protein.

Behavioral: Medium glycemic index

Low glycemic index

EXPERIMENTAL

The participants will be fed a fixed calorie meal, which is low glycemic index with constant fat and protein.

Behavioral: Low glycemic index

Interventions

High glycemic index BEHAVIORAL

Composition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:\>70), 20% fat and 20% protein.

High glycemic index

Medium glycemic index BEHAVIORAL

Composition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:55-70), 20% fat and 20% protein.

Medium glycemic index

Low glycemic index BEHAVIORAL

Composition (by proportion of calories) of meal: 60% carbohydrate (glycemic index:\<55), 20% fat and 20% protein.

Low glycemic index

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults (both men and women)
• years old
• ≤ BMI (body mass index)\<24 kg/m2

You may not qualify if:

• Those who have undergone surgery in the past 6 months.
• People are requiring long-term medication.
• People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al.
• Those who have recently lost weight for various medical reasons (e.g. cancer, etc.).
• People are losing weight by tablets.
• People are suffering from infectious diseases (e.g. HIV, etc.)
• People have blood phobia, pathological hypo or hyper tension.
• People with impaired glucose tolerance.
• Pregnant and lactation women.
• Those who are afflicted with claustrophobia.

Sponsors & Collaborators

• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: lead

Study Sites (1)

Shenzhen Institutes of Advanced Technology

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief scientist

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: April 7, 2023
• Study Start: April 13, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)