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IGF-1

Insulin-like Growth Factor 1, Somatomedin C

Quick Stats
Studies 92
Trials 100
Completed NA INTERVENTIONAL NCT03998878

Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This project will test 3 methods of dietary changes in a weight loss clinic. Participants will be randomized to one of 3 arms: low-carbohydrate diet, intermittent energy restriction, or Hunger Training. A maximum of 30 participants will be assigned to each arm. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic.

Detailed Description

Adult obesity, a common condition in the United States, is a well-established risk factor for the development of chronic diseases, including diabetes, heart disease, hypertension, and many types of cancer. However, research has not determined what type of diet is best for reducing weight and achieving optimal health outcomes. In this randomized trial, participants seeking care at a weight loss clinic will be assigned to one of three diets: low-carbohydrate, intermittent energy restriction, or Hunger Training. On the low-carbohydrate diet, participants will be instructed to consume less than 30 grams of carbohydrates per day. The intermittent energy restriction protocol will require participants to choose 2 non-consecutive days per week in which they will consume 500-650 calories. Hunger Training is a relatively new approach that involves teaching people to monitor their hunger symptoms and blood glucose, and to eat only when blood glucose is below a certain level. To our knowledge, these weight loss modalities have not been compared in a single, clinical study. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic. The goal will be achieved though the successful completion of the following aims: Aim 1: To determine the feasibility of recruiting, retaining and maintaining the adherence participants in a randomized clinical trial testing 3 weight loss modalities. Aim 2: To examine and compare the effect of 3 weight loss modalities on changes in anthropometric measures and metabolic and cancer-related health markers. Aim 3: To evaluate and compare patients' perceived satisfaction with each weight loss modality.

Interventions

Name: Low-Carbohydrate Diet
Type: BEHAVIORAL
Description: Participants will be instructed to follow a low-carbohydrate diet.
Name: Intermittent Energy Restriction
Type: BEHAVIORAL
Description: Participants will be instructed to follow intermittent energy restriction.
Name: Hunger Training
Type: BEHAVIORAL
Description: Participants will be instructed to follow Hunger Training.

Primary Outcomes

Measure: Rate of Recruitment
TimeFrame: 1 year
Description: Feasibility of recruiting participants into a randomized dietary intervention in a clinic setting as measured by the total number of individuals who are screened as eligible and enrolled into the study
Measure: Rate of Retention
TimeFrame: 1 year
Description: Feasibility of retaining participants in a randomized dietary intervention in a clinic setting as measured by the number of participants completing all study visits
Measure: Adherence to the Intervention
TimeFrame: 1 year
Description: Feasibility of maintaining participant adherence in a randomized dietary intervention in a clinic setting will be measured by attendance at scheduled clinic visits
Measure: Change in Weight
TimeFrame: baseline to 3 months
Description: Participant weight will be measured
Measure: Change in BMI
TimeFrame: baseline to 3 months
Description: Participant BMI will be measured
Measure: Change in HbA1c
TimeFrame: baseline to 3 months
Description: Participant HbA1c will be measured
Measure: Change in Fasting Glucose
TimeFrame: baseline to 3 months
Description: Participant fasting glucose will be measured
Measure: Change in Fasting Insulin
TimeFrame: baseline to 3 months
Description: Participant fasting insulin will be measured
Measure: Change in Total Cholesterol
TimeFrame: baseline to 3 months
Description: Participant total cholesterol will be measured
Measure: Change in Triglycerides
TimeFrame: baseline to 3 months
Description: Participant triglycerides will be measured
Measure: Change in High Density Lipoprotein (HDL)
TimeFrame: baseline to 3 months
Description: Participant HDL will be measured
Measure: Change in Low Density Lipoprotein (LDL)
TimeFrame: baseline to 3 months
Description: Participant LDL will be measured
Measure: Change in C-Reactive Protein (CRP)
TimeFrame: baseline to 3 months
Description: Participant CRP will be measured
Measure: Change in Insulin-like Growth Factor 1 (IGF-1)
TimeFrame: baseline to 3 months
Description: Participant IGF-1 will be measured
Measure: Change in Insulin-like Growth Factor 2 (IGF-2)
TimeFrame: baseline to 3 months
Description: Participant IGF-2 will be measured
Measure: Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
TimeFrame: baseline to 3 months
Description: Participant IGFBP-3 will be measured
Measure: Change in Leptin
TimeFrame: baseline to 3 months
Description: Participant leptin will be measured
Measure: Change in Adiponectin
TimeFrame: baseline to 3 months
Description: Participant adiponectin will be measured
Measure: Participant Satisfaction
TimeFrame: 3 months
Description: Participants will complete a questionnaire at the end of the study to assess the acceptability of and satisfaction with the weight loss diet intervention they received. We will assess overall satisfaction, enjoyment, likeliness to recommend, and ease of following the diet. Aggregated scores will be compared across weight loss modality.

Trial Information

NCT ID

NCT03998878

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

University of Arizona

Last Updated

December 15, 2025

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