40 Participants Needed

Low Sugar Protein Pacing + Intermittent Fasting for Weight Loss

PJ
KM
Overseen ByKaren M Arciero, DPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Skidmore College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will systematically quantify the effects of protein pacing and intermittent fasting (P-IF) on total and regional (abdominal) body composition (lean mass and fat mass), blood glucose and lipids, and anti-aging biomarkers, hunger ratings, and the gut microbiome in 40 overweight/obese adult men (n=20) and women (n=20) following a 8-week weight loss intervention. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.

Who Is on the Research Team?

PJ

Paul J Arciero, PhD

Principal Investigator

Skidmore College

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Weight stable (+/-2kg) for at least 6 months prior to beginning the study
Non-smoking, healthy, but overweight/obese men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive medical examination by their physicians
You are considered overweight or obese based on your body mass index (BMI) or percentage of body fat.
See 1 more

Exclusion Criteria

You have chronic obstructive pulmonary disease (COPD).
Fasting intolerances/hypoglycemia
Pregnant or plan to become pregnant during 8-week study
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss Intervention

Participants follow a dietary intervention phase with protein pacing and intermittent fasting or a heart healthy diet

8 weeks
Weekly visits for monitoring and dietary adjustments

Follow-up Case Study

Participants are monitored for weight loss maintenance and health improvements over a long-term period

12 months
Monthly visits for health assessments

Extended Follow-up

Additional follow-up to document long-term weight loss and body composition improvements

12 months
Bi-monthly visits for continued monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • HH
  • P-IF
  • PP-IF
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Protein pacing and intermittent fastingExperimental Treatment1 Intervention
Group II: Heart HealthyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Skidmore College

Lead Sponsor

Trials
20
Recruited
1,100+

Arizona State University

Collaborator

Trials
311
Recruited
109,000+

Isagenix International LLC

Industry Sponsor

Trials
6
Recruited
210+
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