NCT05002491: HiProLep

Change in Leptin as a Predictor of Satiety With High Protein Feeding

Completed NA Last updated 30 August 2021

What this trial tests

NA trial testing High protein diet in Dietary Exposure in 19 participants. Completed in 31 December 2003.

Timeline

1 May 2002

Primary endpoint
31 December 2003

31 December 2003

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	19
Start date	1 May 2002
Primary completion	31 December 2003
Estimated completion	31 December 2003

Drugs / interventions tested

• High protein diet

Conditions studied

• Dietary Exposure — all drugs for Dietary Exposure →

Sponsor

Oregon Health and Science University

Who can join

Adults 18 to 65, any sex, with Dietary Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Body weight can be affected by the content of fat and carbohydrate in the diet. On average, people will lose a modest (\< 5 kg) amount of weight when switched from a high fat diet to a low fat, high carbohydrate diet. Determining mechanisms whereby changing the makeup of the diet can change one's body weight will be important in understanding why body weight in the US population is trending upward recently and what health care providers can recommend to reverse this trend. Previous studies have shown that increasing the carbohydrate and lowering the fat content in the diet leads to a change in the appearance of the hormone leptin in the blood over 24 hours. Leptin is an important signal from the fat cell to the brain that leads to a reduction in appetite and weight loss. A previous study found that after keeping people's weight stable, that the greater rise in leptin over the day on a low fat-high carbohydrate diet compared to a high fat diet predicted the reduction in calories they ate over a subsequent 12 weeks when their weight was allowed to freely fluctuate. Recent studies have also provided evidence that limiting fat and increasing the amount of protein in the diet also leads to modest weight loss. It is therefore proposed to test whether low fat, high protein diets also result a change in leptin secretion, and if this change predicts a reduction in appetite when they are allowed to eat freely.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Self-selected meal composition alters the relationship between same-day caloric intake and appetite scores in humans during a long-term ad-libitum feeding study.
   Horgan AM, Palmbach GR, Jordan JM, Callahan HS, et al · · 2023 · cited 2× · PMID 36346472 · DOI 10.1007/s00394-022-03040-5