Treatment Trials

39 Clinical Trials for Various Conditions

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RECRUITING
The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults
Description

Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets. The present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults. Subjects: 40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 . Protocol: This is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.

RECRUITING
Corn Glycemic Index
Description

Processing sweet corn may impact digestibility and, therefore, glycemic response following consumption. The primary aim of this study is to assess the glycemic index of various sweet corn products and varieties. An exploratory aim is to assess hunger/satiety scores following sweet corn intake.

Conditions
RECRUITING
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
Description

The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are: * Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible. * What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.

Conditions
COMPLETED
Glycemic Index of Table Grape Varietals
Description

Investigate the postprandial glycemic responses of healthy individuals when consuming commercially available table grape varietals or grape juice, compared to a standard amount of glucose.

Conditions
COMPLETED
Providing Personally Tailored Dietary Suggestions Using Individual Microbiome and Glycemic Index Response.
Description

Provide personally tailored dietary suggestions to participants based on the Personalized Prediction Engine (patent pending) owned by DayTwo.

TERMINATED
Glycemic Index of Commonly Consumed Sweeteners
Description

The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.

Conditions
COMPLETED
Fiber Effects on Glycemic Index
Description

Primary outcome measure: Changes in plasma glucose concentration over a 3 hour postprandial visit after administration of polydextrose (12g) compared to 0 mg placebo. Secondary outcome measure: Changes in gastrointestinal tolerance and acute bowel changes in 3 days following treatment administration.

Conditions
COMPLETED
Dietary Glycemic Index, Brain Function and Food Intake in Patients With Type 1 Diabetes Mellitus
Description

Processed carbohydrates cause rapid changes in blood sugar and have been associated with overeating and obesity. We have shown that test meals high in processed carbohydrate affect brain areas involved in addiction, craving and overeating. It is unknown whether the changes in blood sugar or the associated higher insulin levels mediate this brain activation and its likely adverse effects. Answering this question is important for patients with type 1 diabetes who have elevated risks of obesity and disordered eating: If blood sugar is the causal mechanism, optimal insulin coverage should be protective. If insulin is the causal mechanism, however, a diet high in processed carbohydrate could predispose to overeating and weight gain, as this diet requires higher insulin doses. To disentangle these factors, we will study brain activation and relevant blood markers in 15 men with diabetes. In 4 sessions, we will examine meals with differential carbohydrate properties while giving insulin infusions.

COMPLETED
Effect of Fiber on Glycemic Index
Description

Primary objective is to investigate the effect of polydextrose on postprandial glucose concentrations in healthy adults when added to a food product. Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.

Conditions
COMPLETED
Glycemic Index in Mitochondrial Disease
Description

The investigators are conducting a research study on nutrition in mitochondrial disease. The investigators are interested in the kind of carbohydrates that people eat. Carbohydrates are an important source of energy. Certain kinds of carbohydrates tend to raise blood sugar more in healthy people, and others tend to raise blood sugar less in healthy people. The investigators would like to know if by eating the "right" type of carbohydrate, people with mitochondrial disease can avoid high lactate levels, high blood sugar levels, and, later, low blood sugars. In this study, this question will be answered by finding out how people with mitochondrial disease respond to two different test meals containing different kinds of carbohydrates. Neither participants nor the investigators will know which kind of test meal participants are eating.

COMPLETED
Effect of Dietary Glycemic Index on Beta-cell Function
Description

The study will determine if increasing the highs and lows of blood glucose levels (glycemic variability) impairs insulin secretion in people with impaired glucose tolerance and/or impaired fasting glucose who are at risk for developing type 2 diabetes. Furthermore, the study will determine whether changes in beta-cell function are associated with glycemic variability and whether they are mediated by oxidative stress. To decrease or increase glycemic variability the study will provide subjects with special diets containing either low or high glycemic index foods respectively for 4 weeks. To determine if oxidative stress is a mediator, subjects on the high glycemic index diet will take either placebo or the anti-oxidant N-acetylcysteine. The study will address the hypothesis that increased glycemic variability results in increased oxidative stress and thereby exacerbates beta-cell dysfunction in individuals with impaired glucose tolerance and/or impaired fasting glucose. The findings may have important implications for the development of effective strategies aimed at the prevention and treatment of type 2 diabetes. In addition, understanding the contribution of dietary glycemic index to beta-cell dysfunction in subjects with pre-diabetes may have a significant public health impact, including changes to dietary counseling and promotion of healthier eating patterns.

TERMINATED
Effect of a Low Glycemic Index Diet on Breast Density
Description

This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.

Conditions
COMPLETED
Continuous Glucose Monitoring to Measure Effect of Glycemic Index
Description

Background: Post-prandial hyperglycemia is common in people with type 1 diabetes. Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring. Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.

COMPLETED
Glycemic Index and Brain Function
Description

The investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies.

Conditions
COMPLETED
Glycemic Index - Variability Among Individuals
Description

The purpose of this study is to determine the variability in glycemic index determinations for individual foods and food combinations. The study will also evaluate the changes in insulin and free fatty acid levels, plasma lipid and lipoprotein profiles, C-reactive protein-a marker of inflammation and glycosylated hemoglobin- a marker of glucose metabolism during a five-hour period after eating the food or foods. Additionally, supplementary data on variation in oral sensation, habitual food intake, food preferences and genes mediating sensory perception and dietary behaviors (supported by a grant from the Tufts Ross Aging Initiative) will be related to the outcomes on the present study.

COMPLETED
Glycemic Index and CVD: a Crossover Feeding Study
Description

This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day crossover feeding trial.

Conditions
COMPLETED
Effect of Added Fruit Pomace Fiber, Juice, and Whole Fruit on Postprandial Glycemia
Description

Compare the effects of whole orange, orange juice alone, and orange juice with added orange pomace fiber, and whole apple, apple juice alone, and apple juice with added apple pomace fiber, on 2h glycemic response.

Conditions
TERMINATED
GRAPE • Glycemic Response of Amylopectin Containing Drinks
Description

To quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index. The aim of the study is to quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.

Conditions
COMPLETED
Replace Glycemic Load and Satiety Study
Description

The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.

COMPLETED
Incorporating Avocados in Meals
Description

The purpose of this study is to examine the effect of incorporating avocados in meals on post-ingestion glycemic index, insulin response, sensations of satiety and on appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming avocado containing meals on the caloric intake of participants in subsequent eating episodes will be explored. Each subject will participate in one intervention for one day, wait one or two weeks, come for another intervention, wait one or two weeks and come for a final intervention- three in total. Participants will be randomly assigned to one of six treatment sequences. Postprandial response to the control and two avocado-containing test meals will be assessed and compared using a 3 x 3 single blind cross-over design. The Subjects will be between 25 and 60 years old, female or male, with a BMI of 23 to 32, stable weight, no sports involvement, non-smoking and not dependent on caffeine. Thirty subjects will be recruited.

NOT_YET_RECRUITING
Low-Glycemic (LGI) Diet in Pregnant People With Epilepsy
Description

The goal of this clinical trial is to learn about the low glycemic index diet in pregnant people with epilepsy. The main questions it aims to answer are: * Is the low glycemic index tolerable in pregnant people with epilepsy? * Does the low glycemic index alter seizure frequency in pregnant people with epilepsy? * Does the low glycemic index alter the gut bacteria \& associated metabolic pathways in pregnant people with epilepsy? Participants will start the low glycemic index diet during pregnancy and will provide stool and blood samples a maximum of 3 times during study duration. Researchers will compare pregnant people with epilepsy on the diet to pregnant people with epilepsy not on a structured diet plan to see if tolerability, seizure frequency, and gut bacteria composition \& metabolites differ.

Conditions
COMPLETED
Effect of Mango Consumption on Individuals with Pre-diabetes
Description

This study is designed to explore the effect of mango consumption on glycemic indices, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.

COMPLETED
Low-GI Diet Vs High-GI Diet in Individuals with SCI
Description

The purpose of this pilot research project is to examine the impact of a low-glycemic index (GI) diet on postprandial hypotension and glucose control in individuals with chronic spinal cord injury. The objectives are: 1) To evaluate the effect of the low-GI diet on the magnitude of postprandial systolic blood pressure drop compared to a high-GI control diet. 2)To evaluate the effect of a low-GI diet on postprandial glucose and insulin responses compared to a high-GI control diet.

ACTIVE_NOT_RECRUITING
Low GI Diet in Children and Adolescents With ALL
Description

The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia.

COMPLETED
Postprandial Glycemic Response to Polyphenol-fortified Snack Bars
Description

Consuming plant chemicals (e.g., polyphenols) may have beneficial effects on human health that, if confirmed, may warrant inclusion in combat rations. Ration developers would like to determine whether the fortification of a high sugar food item with a polyphenol-rich freeze-dried fruit and/or a fruit extract improves blood sugar response and promotes other positive physiological changes (e.g., satiety) in a dose-response manner. This study will test four different types of snack bar with various polyphenol doses, and compare blood response to a snack bar without polyphenols.

SUSPENDED
A Nutritional Intervention in Police Officers
Description

The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.

COMPLETED
Framingham State Food Study
Description

This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.

SUSPENDED
Plant-Based Dietary Intervention in Type 2 Diabetes-2
Description

The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.

COMPLETED
Practice Based Nutrition Intervention-2
Description

This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes. The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.

SUSPENDED
Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
Description

The purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes.