Effect of Carbonated Prebiotic Beverages Versus Caloric and Non-caloric Beverages on Satiety, Glucose, Insulin, and GLP-1 Response in Healthy Male Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Glucose
研究概览
简要总结
The study aims to study healthy men aged 18-40 to explore how different beverages affect hunger, blood sugar, insulin, and a hormone called GLP-1, which helps regulate appetite and blood sugar. The tested beverages include two prebiotic sodas (Olipop and Poppi), Diet Coke, and Coca-Cola Classic.
What's the study about? It aims to understand how these drinks influence how full participants feel and how the body handles sugar and hormones compared to each other. This could help us learn more about how prebiotic drinks, which may support gut health, compare to regular sugary or diet sodas.
What will participants do?
Participants will visit our lab at TCU (Rickel Building, rooms 256/259) four times over four weeks, with each visit lasting about 2-2.5 hours. Participants will need to fast for 8-12 hours before each visit. Here's what happens:
- First visit involves participants' consent, measurement of height and weight, and performing a finger-stick test to check blood sugar and HbA1C. Participants will also fill out questionnaires about health, diet, and beverage preferences.
- Visits 2-4: In visit 2, a DEXA scan will be performed to assess body composition. In visits 2-4, participants will drink one of the four beverages (in a random order, served in an unlabeled black container to prevent drink identification). Other variables measured at these time points include blood pressure, fasting glucose, insulin, and GLP-1. Participants will also complete questionnaires about hunger and how the drink tastes.
Each visit is spaced out by a week, and the total time commitment is about 10.5 hours. The study is expected to complete participant recruitment by December 10, 2025.
Who can join? Ten healthy men aged 18-40 who don't have diabetes, heart disease, kidney or liver issues, or other specific health conditions. Participants shouldn't smoke, vape, or have certain dietary habits like intermittent fasting. Participants will be screened to confirm eligibility.
What are the risks? The risks are low but include discomfort from blood draws or the IV catheter, a small chance of infection, and minimal radiation exposure from the DEXA scan (similar to everyday background radiation). There's also a small risk of a data breach, but participant information will be secured with password-protected systems and use ID numbers instead of names.
What do participants get? Participants will receive a DEXA scan, baseline blood sugar, and HbA1C tests. If participants have abnormal results (like high blood sugar), doctor visits would be recommended. There are no direct benefits to participants, but participation could help develop better dietary recommendations in the future.
How is privacy protected? Data will be stored securely on password-protected computers and in locked lab facilities, following HIPAA rules. Blood samples will be frozen for up to 10 years for possible future research (with participants' consent) and labeled with an ID number, not participants' names.
How to join? Participants will be recruited through flyers, emails, social media, and TCU classes. If interested, participants will complete an online screening form or scan a QR code on our flyer. If eligible, participants will be contacted to confirm details and explain the study further.
If participants have questions or want to join, contact Dr. Elisa Marroquin at e.marroquin@tcu.edu or Matthew Loritz at m.loritz@tcu.edu. Participation is voluntary, and participants can withdraw at any time, though data will be kept for analysis.
详细描述
Study Overview This research study, conducted by the Texas Christian University (TCU) Department of Nutritional Sciences and Kinesiology, aims to investigate the effects of carbonated prebiotic beverages (Olipop and Poppi) compared to caloric (Coca-Cola Original) and non-caloric (Diet Coke) beverages on satiety, blood glucose, insulin, and glucagon-like peptide-1 (GLP-1) responses in healthy male participants aged 18-40. The study is a single-blind, randomized crossover trial designed to explore how these beverages influence metabolic and appetite-related outcomes, addressing gaps in understanding the physiological impacts of functional beverages containing prebiotics versus widely consumed caloric and non-caloric alternatives.
Objectives and Hypotheses The primary objective is to evaluate the acute effects of four beverages-Olipop, Poppi, Diet Coke, and Coca-Cola Classic-on satiety, plasma glucose, insulin, and GLP-1 levels. Secondary objectives include assessing body composition and beverage palatability and gastrointestinal (GI) symptoms. The hypothesis is that prebiotic beverages will enhance satiety and GLP-1 secretion due to fiber content, potentially via gut microbiota fermentation, without significantly increasing glucose or insulin levels compared to Coca-Cola. Diet Coke may elicit a modest GLP-1 and satiety response due to artificial sweeteners, but minimal glucose/insulin changes. Coca-Cola is expected to cause significant glucose and insulin spikes due to its high sugar content. Additionally, hunger is expected to be reduced across all conditions, with prebiotic beverages potentially showing superior satiety effects.
Study Design
- Type: Prospective, interventional, single-blind, randomized crossover trial.
- Participants: 10 healthy males aged 18-40, accounting for a 30% attrition rate.
- Duration: Four visits, each 2-2.5 hours, separated by a one-week washout period (total ~10.5 hours).
- Randomization and Blinding: Each participant consumes all four beverages in random order, served in unlabeled black containers to minimize bias.
- Data Collection: Anthropometric measurements, body composition (DEXA scan), biochemical markers (glucose, insulin, GLP-1), and survey data (satiety, GI symptoms, beverage preference) are collected.
Study Procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Gender: Male
- •Age: 18-40 years
- •Health Status: Healthy, with no significant medical conditions
- •Body Mass Index (BMI): 18.5-24.9 kg/m²
排除标准
- •Diabetes: Diagnosed diabetes (Type 1 or Type 2)
- •Gastrointestinal Disorders: Any diagnosed gastrointestinal conditions (e.g., irritable bowel syndrome, inflammatory bowel disease)
- •Liver Disease: Any diagnosed liver conditions
- •Kidney Disease: Any diagnosed kidney conditions
- •Cardiovascular Disease: Any diagnosed cardiovascular conditions
- •Hypertension: Diagnosed high blood pressure
- •Recent Illness or Infection: Any illness or infection within the past 30 days that could affect study outcomes
- •Tobacco or Nicotine Use: Current use of tobacco or nicotine products (e.g., smoking, vaping)
- •Phenylketonuria (PKU): A genetic disorder affecting phenylalanine metabolism, due to the presence of aspartame in Diet Coke
- •Medication Use: Use of medications or supplements that affect glucose metabolism, insulin response, or appetite
- •Intermittent Fasting: Engagement in intermittent fasting or inconsistent time-restricted feeding patterns
- •Other Health Conditions: Any other health conditions that, in the opinion of the investigators, could interfere with study participation or outcomes
研究组 & 干预措施
Prebiotic Soda 1
Olipop is a low-calorie, carbonated prebiotic beverage (~20-35 kcal per 355 mL serving).
干预措施: Prebiotic Soda 1 (Other)
Prebiotic Soda 2
Poppi is a low-calorie, carbonated prebiotic beverage (~20-35 kcal per 355 mL serving).
干预措施: Prebiotic Soda 2 (Other)
Diet Coke
Diet Coke is a non-caloric, carbonated beverage sweetened with artificial sweeteners. It contains zero calories and zero sugar
干预措施: Diet Soda (Other)
Coca Cola
Coca Cola is a caloric carbonated beverage containing high fructose corn syrup as its primary sweetener. It is considered to be a high-caloric drink (140 kcal per 355 mL serving) with 39 g of sugar.
干预措施: Regular Coke (Other)
结局指标
主要结局
Glucose
时间窗: At baseline and at 15, 30, 60, 90, and 120 minutes
The AUC of plasma glucose concentrations will be compared between the four conditions.
Satiety
时间窗: At baseline and at 15, 30, 60, 90, and 120 minutes
Subjective feelings of hunger and fullness following beverage consumption will be measured using a self-created 10-point Likert-type scale in which higher numbers will mean higher satiety/fullness. Minimum score, equal to zero, means extremely hungry, whereas maximum score, equal to 10, means extremely stuffed.
Insulin
时间窗: At baseline and at 15, 30, 60, 90, and 120 minutes
The AUC of plasma insulin concentrations will be compared between the 4 conditions.
GLP-1
时间窗: At baseline and at 15, 30, 60, 90, and 120 minutes
The AUC of GLP-1 will be compared between the 4 conditions.
次要结局
- Gastrointestinal Symptoms(24h after each the visit)
- Beverage Palatability(After beverage consumption)
研究者
Elisa Marroquin
Assistant Professor
Texas Christian University