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Low Sugar Protein Pacing + Intermittent Fasting for Weight Loss
N/A
Waitlist Available
Led By Paul J Arciero, PhD
Research Sponsored by Skidmore College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 weeks, 8 weeks, 1 year and 2 year of the case study
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of protein pacing and intermittent fasting on weight loss, body composition, blood sugar, lipids, and other markers in 40 obese men and women.
Who is the study for?
This trial is for overweight or obese non-smoking men and women who have been weight stable for the past 6 months, with no cardiovascular or metabolic diseases. They should be sedentary or lightly active and not pregnant. People with diabetes, significant heart disease, eating disorders, certain allergies, cancer treatments, or fasting intolerances cannot join.
What is being tested?
The study tests a diet called protein pacing combined with intermittent fasting (P-IF) over an 8-week period to see its effects on body composition, blood sugar levels, lipids (fats), anti-aging markers, hunger feelings and gut health. Participants will also follow up for an additional year to monitor long-term weight loss maintenance.
What are the potential side effects?
Potential side effects may include discomfort from dietary changes such as hunger during fasting periods; digestive issues due to new foods introduced in the diet; possible nutrient deficiencies if the diet lacks variety; and fatigue due to calorie restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 weeks, 8 weeks, 1 year and 2 year of the case study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 weeks, 8 weeks, 1 year and 2 year of the case study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in body weight
Secondary study objectives
Change in blood lipid levels
Change in blood pressure
Change in energy intake
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Protein pacing and intermittent fastingExperimental Treatment1 Intervention
During the 8-week weight loss (WL) phase, participants assigned to the P-IF will consist of P days, whereby female participants will consume four and male participants will consume five meals/snacks total, two of which (breakfast and lunch) will include a protein powder meal replacement mixed with water (240-400 kcals per meal) along with an evening dinner meal (\~500 kcals), an afternoon snack (men only), and an evening snack (250 kcals). Subjects will be calorie restricted to \~1500 and \~1800 calories per day, women and men, respectively during P days. For each IF day, subjects will be provided a variety of supplements/snacks made by Isagenix International LLC. The P-IF group will be further divided into two subgroups for weeks 1-4. One subgroup will consist of five days of P and two days of IF, and the second subgroup will consist of six days of P and one day of IF. For weeks 5-8 both subgroups will follow 6 days of a P diet and 1 day IF.
Group II: Heart HealthyExperimental Treatment1 Intervention
The HH group will observe the dietary guidelines in compliance with the National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet. This diet consists of consuming \<35% of kcal as fat; 50%-60% of kcal as carbohydrates; \<200 mg/dL of dietary cholesterol; and 20-30 g/day of fiber. The total calorie intake will be 1200 and 1500 calories per day, women and men, respectively during the weight loss phase (weeks 0-8).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HH
2013
N/A
~50
Find a Location
Who is running the clinical trial?
Skidmore CollegeLead Sponsor
19 Previous Clinical Trials
1,072 Total Patients Enrolled
Arizona State UniversityOTHER
303 Previous Clinical Trials
108,048 Total Patients Enrolled
Isagenix International LLCIndustry Sponsor
5 Previous Clinical Trials
174 Total Patients Enrolled
Paul J Arciero, PhDPrincipal InvestigatorSkidmore College
4 Previous Clinical Trials
113 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have chronic obstructive pulmonary disease (COPD).You have Type II Diabetes.You have a condition called emphysema.You have a condition where you eat very little or have episodes of binge eating and purging.You have a serious heart condition such as heart failure, heart attack, or high blood pressure that is not under control.You are considered overweight or obese based on your body mass index (BMI) or percentage of body fat.You don't exercise regularly and are mostly inactive.You have cancer or are currently receiving treatment for cancer.You are allergic to milk, milk products, sugar alcohols, fructose, or gluten.
Research Study Groups:
This trial has the following groups:- Group 1: Protein pacing and intermittent fasting
- Group 2: Heart Healthy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.