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

NCT05002491 | Completed

• 1 other identifier: Protocol 695
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dietary Exposure

Keywords

protein

Outcome Measures

Primary Outcomes (3)

• 24 hour levels of leptin after isocaloric and ad-libitum feeding phases

  Change in leptin levels measured every 30 minutes while consuming diet-assigned meals

  After each 2 week isocaloric feeding phase (x2) and a 3 month ad-lib feeding phase

• 24 hour levels of ghrelin after isocaloric and ad-libitum feeding phases

  Change in ghrelin levels measured every 30 minutes while consuming diet-assigned meals

  After each 2 week isocaloric feeding phase (x2) and a 3 month ad-lib feeding phase

• Body weight

  Change in body weight

  Weekly during each 2 week isocaloric feeding phase (x2) and a 3 month ad-lib feeding phase

Secondary Outcomes (2)

• Appetite scores

  Daily during each 2 week isocaloric feeding phase (x2) and a 3 month ad-lib feeding phase

• Lipid levels at each study visit

  Daily during each 2 week isocaloric feeding phase (x2) and a 3 month ad-lib feeding phase

Study Arms (1)

High protein feeding

EXPERIMENTAL

Two isocaloric feeding phases of 2 weeks followed by an ad-libitum feeding phase of 3 months

Other: High protein diet

Interventions

High protein diet OTHER

Normal vs high protein dietary feeding

High protein feeding

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed written consent
• Age between 18 and 65 years
• Willingness to consume only food prepared by the CRC for 6 weeks
• Body mass index between 22 and 28 kg/m2
• Weight stable to within 2 kg for 3 months preceding study, and at lifetime maximal weight

You may not qualify if:

• Diabetes mellitus
• Renal disease
• Other chronic medical or psychiatric illness
• Pregnancy or female subject unwilling to use contraception
• Use of tobacco products
• Regular intense exercise (\>30 minutes of aerobics, 3x / week)
• Vegetarian or extreme dietary preferences (\< 20% or \> 40% fat diet, \> 40% protein diet)
• Use of anabolic steroids, glucocorticoids, or lipid-lowering agents
• Alcohol consumption \>2 drinks / day

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (5)

• Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41.

  PMID: 16002798 BACKGROUND

• Koren MS, Purnell JQ, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Weigle DS. Changes in plasma amino Acid levels do not predict satiety and weight loss on diets with modified macronutrient composition. Ann Nutr Metab. 2007;51(2):182-7. doi: 10.1159/000103323. Epub 2007 May 30.

  PMID: 17541265 BACKGROUND

• Kratz M, Weigle DS, Breen PA, Meeuws KE, Burden VR, Callahan HS, Matthys CC, Purnell JQ. Exchanging carbohydrate or protein for fat improves lipid-related cardiovascular risk profile in overweight men and women when consumed ad libitum. J Investig Med. 2010 Jun;58(5):711-9. doi: 10.231/JIM.0b013e3181da4d37.

  PMID: 20305576 BACKGROUND

• Kremsdorf RA, Hoofnagle AN, Kratz M, Weigle DS, Callahan HS, Purnell JQ, Horgan AM, de Boer IH, Kestenbaum BR. Effects of a high-protein diet on regulation of phosphorus homeostasis. J Clin Endocrinol Metab. 2013 Mar;98(3):1207-13. doi: 10.1210/jc.2012-2910. Epub 2013 Feb 7.

  PMID: 23393178 BACKGROUND

• Horgan AM, Palmbach GR, Jordan JM, Callahan HS, Meeuws KE, Weigle DS, Kratz M, Purnell JQ. 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. Eur J Nutr. 2023 Mar;62(2):1003-1009. doi: 10.1007/s00394-022-03040-5. Epub 2022 Nov 8.

  PMID: 36346472 DERIVED

MeSH Terms

Interventions

Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Isocaloric feeding phase followed by ad-libitum feeding phase

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 12, 2021
• Study Start: May 1, 2002
• Primary Completion: December 31, 2003
• Study Completion: December 31, 2003
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share