NCT04327141

Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women

Active, enrolled NA Last updated 8 April 2024

What this trial tests

NA trial testing P-IF in Weight Loss in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 September 2020

Primary endpoint
1 April 2023

31 December 2024

Quick facts

Lead sponsor	Skidmore College
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	3 September 2020
Primary completion	1 April 2023
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• P-IF
• HH

Conditions studied

• Weight Loss — all drugs for Weight Loss →
• Gut Microbiome — all drugs for Gut Microbiome →
• Anti-Aging — all drugs for Anti-Aging →

Sponsor

Skidmore College

Who can join

Adults 25 to 65, any sex, with Weight Loss or Gut Microbiome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiome remodeling and metabolomic profile improves in response to protein pacing with intermittent fasting versus continuous caloric restriction.
   Mohr AE, Sweazea KL, Bowes DA, Jasbi P, et al · · 2024 · cited 58× · PMID 38806467 · DOI 10.1038/s41467-024-48355-5
2. Gut dysbiosis and age-related neurological diseases; an innovative approach for therapeutic interventions.
   Holmes A, Finger C, Morales-Scheihing D, Lee J, et al · · 2020 · cited 43× · PMID 32755639 · DOI 10.1016/j.trsl.2020.07.012
3. Intermittent fasting and protein pacing are superior to caloric restriction for weight and visceral fat loss.
   Arciero PJ, Poe M, Mohr AE, Ives SJ, et al · · 2023 · cited 27× · PMID 36575144 · DOI 10.1002/oby.23660
4. Exploratory analysis of one versus two-day intermittent fasting protocols on the gut microbiome and plasma metabolome in adults with overweight/obesity.
   Mohr AE, Jasbi P, Bowes DA, Dirks B, et al · · 2022 · cited 19× · PMID 36386914 · DOI 10.3389/fnut.2022.1036080
5. The Effect of Intermittent Fasting on Appetite: A Systematic Review and Meta-Analysis.
   Elsworth RL, Monge A, Perry R, Hinton EC, et al · · 2023 · cited 17× · PMID 37299567 · DOI 10.3390/nu15112604
6. Intermittent fasting two days versus one day per week, matched for total energy intake and expenditure, increases weight loss in overweight/obese men and women.
   Arciero PJ, Arciero KM, Poe M, Mohr AE, et al · · 2022 · cited 14× · PMID 35658959 · DOI 10.1186/s12937-022-00790-0
7. Intermittent Fasting Two Days per Week versus One Day per Week, Matched for Total Energy Intake and Expenditure, Increases Weight Loss in Overweight/Obese Men and Women
   Arciero PJ, Arciero KM, Poe M, Mohr AE, et al · · 2022 · DOI 10.21203/rs.3.rs-1269302/v1